Boston Scientific Corporation
Medical device manufacturer in Marlborough, MA.
732510(k) clearances
75PMA approvals
1,059recalls
Device types
- FGE Stents, Drains And Dilators For The Biliary… 56
- LIT Catheter, Angioplasty, Peripheral… 52
- DQX Wire, Guide, Catheter 34
- DQY Catheter, Percutaneous 30
- DQO Catheter, Intravascular, Diagnostic 20
- KNS Unit, Electrosurgical, Endoscopic (With Or… 18
- DYB Introducer, Catheter 16
- KRD Device, Vascular, For Promoting Embolization 16
- ESW Prosthesis, Esophageal 15
- GEI Electrosurgical, Cutting & Coagulation &… 15
- DQK Computer, Diagnostic, Programmable 15
- DSP System, Balloon, Intra-Aortic And Control 14
- DRF Catheter, Electrode Recording, Or Probe… 14
- OBJ Catheter, Ultrasound, Intravascular 12
- FAD Stent, Ureteral 12
- KRA Catheter, Continuous Flush 11
- GEX Powered Laser Surgical Instrument 11
- HCG Device, Neurovascular Embolization 11
- ITX Transducer, Ultrasonic, Diagnostic 10
- KNT Tubes, Gastrointestinal (And Accessories) 10
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K262151 | SpaceOAR Flex SystemOVB · Traditional | 09/11/2026SE |
| K262460 | Rezum SystemKNS · Traditional | 09/03/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | 08/26/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | 08/21/2026SE |
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | 08/12/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | 08/04/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | 07/24/2026SE |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | 07/24/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | 07/10/2026SE |
| K260428 | RIVOS EUS Access Device (M00553900)ODG · Traditional | 06/17/2026SE |
| K260100 | MOSES RaydarGEX · Traditional | 05/18/2026SE |
| K260771 | TruSelect 2.6 MicrocatheterKRA · Special | 05/15/2026SE |
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter…OBJ · Special | 04/08/2026SE |
| K251273 | Asurys Fluid Management SystemHIG · Traditional | 03/27/2026SE |
| K260479 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | 03/13/2026SE |
| K260119 | SpaceOAR Vue System (SV-2101)OVB · Special | 02/10/2026SE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | 10/30/2025SE |
| K252529 | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110)…GEX · Traditional | 10/30/2025SE |
| K252547 | TheraSphere 360 Y-90 Management PlatformLLZ · Traditional | 10/28/2025SE |
| K252910 | Orca Air/Water and Suction ValvesODC · Special | 10/09/2025SESK |
| K252921 | Radial Jaw 4 Pulmonary Biopsy ForcepsBWH · Special | 09/26/2025SE |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure…FGB · Special | 09/24/2025SE |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)MXD · Special | 09/12/2025SE |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…GEX · Special | 07/09/2025SE |
| K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System…FGE · Traditional | 07/03/2025SE |
| K250310 | VIKING Fixed Curve Diagnostic CatheterDRF · Traditional | 06/27/2025SE |
| K250584 | Rezum SystemKNS · Traditional | 06/11/2025SE |
| K251344 | OptiMap SystemDQK · Special | 05/28/2025SE |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive…FAD · Special | 04/15/2025SE |
| K250517 | Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD…FED · Special | 03/21/2025SE |
| K250468 | iSLEEVE Introducer SetDYB · Special | 03/20/2025SE |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602)…PKL · Special | 02/06/2025SE |
| K242950 | WallFlex Biliary PLUS RX Stent SystemFGE · Traditional | 12/06/2024SESU |
| K242960 | AdVance XP Male Sling System (720163-03)OTM · Traditional | 11/15/2024SE |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional…DRF · Traditional | 11/01/2024SE |
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…GEH · Special | 10/18/2024SE |
| K242507 | OBSIDIO Conformable EmbolicKRD · Special | 10/03/2024SE |
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…FGE · Traditional | 08/30/2024SESU |
| K241227 | RHYTHMIA HDx Mapping SystemDQK · Traditional | 08/29/2024SE |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling…LIT · Special | 07/10/2024SE |
| K241598 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…FGB · Special | 07/01/2024SE |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemESW · Traditional | 04/29/2024SE |
| K233837 | Agile Esophageal Stent SystemESW · Traditional | 04/04/2024SE |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02)GEH · Traditional | 03/13/2024SE |
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…MQR · Special | 03/08/2024SE |
| K240018 | WATCHMAN TruSteer Access System (M635TU90050)DQY · Special | 02/01/2024SE |
| K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse…FGB · Special | 12/12/2023SE |
| K233248 | FARADRIVE Steerable SheathDRA · Traditional | 12/11/2023SE |
| K233503 | 14F iSLEEVE Introducer SetDYB · Special | 11/30/2023SE |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar…KNS · Traditional | 11/28/2023SE |
| K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)GEH · Special | 11/22/2023SE |
| K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and…KNS · Special | 10/27/2023SE |
| K233207 | Polaris X Unidirectional Steerable Diagnostic CatheterDRF · Special | 10/27/2023SE |
| K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic CatheterDRF · Special | 09/29/2023SE |
| K230884 | AVVIGO'+ Multi-Modality Guidance SystemDQK · Traditional | 09/26/2023SE |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312)MXD · Traditional | 08/19/2023SE |
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44…KNS · Special | 08/14/2023SE |
| K230551 | Visual-ICE Cryoablation SystemGEH · Traditional | 08/08/2023SE |
| K223633 | Rubicon Control Support Catheter (H749394323506A1)DQY · Traditional | 08/08/2023SE |
| K230269 | Ultraflex Tracheobronchial Stent SystemJCT · Special | 07/14/2023SE |
| K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemOTN · Special | 06/29/2023SE |
| K230706 | EMBOLD Soft Detachable Coil SystemKRD · Traditional | 06/27/2023SE |
| K231533 | Habib EndoHPBKNS · Special | 06/21/2023SE |
| K223469 | WallFlex Biliary RX Stent SystemFGE · Traditional | 06/15/2023SESU |
| K231176 | Stingray LP CatheterDQY · Special | 05/25/2023SE |
| K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging CatheterOBJ · Special | 05/18/2023SE |
| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter CableDRF · Traditional | 04/25/2023SE |
| K223824 | POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping…DRA · Traditional | 03/22/2023SE |
| K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…EOQ · Traditional | 03/02/2023SE |
| K230051 | 14F iSLEEVE Introducer SetDYB · Special | 02/03/2023SE |
| K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…FGB · Traditional | 02/02/2023SE |
| K223616 | Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceODG · Special | 12/30/2022SE |
| K223592 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System…FGE · Special | 12/29/2022SE |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…FAD · Traditional | 11/10/2022SESK |
| K222568 | OptiCross 18 Peripheral Imaging CatheterOBJ · Special | 09/23/2022SE |
| K222503 | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA ClipPKL · Special | 09/14/2022SE |
| K220112 | AXIOS Stent and Electrocautery-Enhanced Delivery SystemPCU · Traditional | 09/07/2022SE |
| K220962 | ROTAPRO Rotational Atherectomy SystemMCW · Traditional | 09/06/2022SE |
| K221124 | MANTIS ClipPKL · Traditional | 08/04/2022SE |
| K222014 | EXALT Model B Single-Use BronchoscopeEOQ · Special | 07/28/2022SE |
| K220796 | IntellaMap Orion High Resolution Mapping CatheterDRF · Special | 06/10/2022SE |
| K212582 | SpyGlass Discover Balloon Dilation CatheterGCA · Traditional | 05/06/2022SE |
| K220866 | EKOS+ Endovascular DeviceQEY · Special | 04/20/2022SE |
| K213398 | EMBOLD Fibered Detachable Coil SystemKRD · Traditional | 04/12/2022SE |
| K220629 | Emerge Monorail PTCA Dilatation CatheterLOX · Special | 03/24/2022SE |
| K203548 | EndoArmor + Surgical GownFYA · Traditional | 02/21/2022SE |
| K213593 | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDOBJ · Special | 01/14/2022SE |
| K211847 | AdVance XP Male Sling SystemOTM · Traditional | 12/20/2021SE |
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular DeviceQEY · Traditional | 12/14/2021SE |
| K211960 | Agile Esophageal OTW Stent SystemESW · Traditional | 11/22/2021SE |
| K211080 | EkoSonic Endovascular DeviceQEY · Traditional | 11/19/2021SE |
| K212490 | AVVIGO Guidance System IIDQK · Special | 10/20/2021SE |
| K211494 | Polaris X Unidirectional Steerable Diagnostic CatheterDRF · Traditional | 09/14/2021SE |
| K211375 | Blazer Dx-20 Bidirectional Steerable Diagnostic CatheterDRF · Traditional | 09/10/2021SE |
| K212228 | WATCHMAN FXD Curve Access SystemDQY · Special | 08/13/2021SE |
| K211030 | EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope…EOQ · Traditional | 08/09/2021SE |
| K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemOTN · Traditional | 07/21/2021SE |
| K210889 | iLab Polaris Multi-Modality Guidance SystemDQK · Special | 06/25/2021SE |
| K203322 | SpyGlass Discover Retrieval BasketLQR · Traditional | 05/26/2021SE |
| K210608 | LUX-Dx Insertable Cardiac MonitorMXD · Special | 05/25/2021SE |
| K210353 | AutoCap RXODC · Traditional | 05/06/2021SE |
| K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…GEX · Traditional | 04/28/2021SE |
| K211072 | Safety Trocar CannulaKNT · Traditional | 04/27/2021SE |
| K200260 | Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex…FAD · Traditional | 04/26/2021SESK |
| K203132 | AXIOS Stent and Electrocautery Enhanced Delivery SystemPCU · Traditional | 04/15/2021SE |
| K203162 | Advanix Biliary Stent with NaviFlex RX Delivery SystemFGE · Traditional | 12/18/2020SE |
| K200404 | ORISE ProKnifeKNS · Traditional | 12/03/2020SE |
| K202478 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy SnaresFDI · Special | 10/08/2020SE |
| K202584 | iSleeve Introducer SetDYB · Special | 10/06/2020SE |
| K202218 | ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation DeviceQEW · Traditional | 10/02/2020SE |
| K201170 | Athletis PTA Balloon Dilatation CatheterLIT · Traditional | 09/15/2020SE |
| K193424 | Resolution 360 ULTRA ClipPKL · Traditional | 09/01/2020SE |
| K202224 | SpaceOAR SystemOVB · Special | 08/28/2020SE |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery SystemMQR · Traditional | 08/17/2020SE |
| K201792 | TRUSELECT MicrocatheterKRA · Special | 07/28/2020SE |
| K201713 | AVVIGO Guidance SystemDQK · Special | 07/23/2020SE |
| K193473 | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…MXD · Traditional | 06/26/2020SE |
| K201178 | iLab Polaris Multi-Modality Guidance SystemDQK · Special | 05/29/2020SE |
| K200483 | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerFBN · Traditional | 05/21/2020SE |
| K200733 | Opticross 35 15 MHz Peripheral Imaging CatheterITX · Special | 04/17/2020SE |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…MQR · Traditional | 04/17/2020SE |
| K192460 | Sentinel Cerebral Protection SystemPUM · Special | 02/19/2020SE |
| K191538 | Resectr Tissue Resection DeviceHIH · Traditional | 01/16/2020SE |
| K191446 | Ureteral Stent Systems, Biliary Drainage CathetersFAD · Traditional | 01/02/2020SESK |
| K193279 | Comet II Pressure GuidewireDXO · Special | 12/23/2019SE |
| K193202 | EXALT Model D Single-Use Duodenoscope, EXALT ControllerFDT · Traditional | 12/13/2019SE |
| K192438 | Rhythmia HDxTM Mapping SystemDQK · Traditional | 11/27/2019SE |
| K192360 | IntellaMap Orion High Resolution Mapping CatheterDRF · Traditional | 10/25/2019SE |
| K192043 | AXIOS Stent and Electrocautery Enhanced Delivery SystemPCU · Traditional | 08/26/2019SE |
| K191609 | Tria Soft Ureteral StentFAD · Traditional | 08/16/2019SE |
| K191871 | 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetDYB · Special | 08/07/2019SE |
| K191789 | Stonetome Stone Removal DeviceLQR · Special | 07/25/2019SESK |
| K191008 | iLab Polaris Multi-Modality Guidance SystemDQK · Traditional | 07/02/2019SE |
| K190603 | Tria Firm Ureteral StentFAD · Special | 05/24/2019SE |
| K182975 | Mako 7HIH · Traditional | 05/21/2019SE |
| K183619 | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra…FAE · Traditional | 04/16/2019SE |
| K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemPCU · Traditional | 03/25/2019SE |
| K190401 | MAMBA and MAMBA Flex MicrocathetersDQY · Special | 03/15/2019SE |
| K183177 | Nitinol Thermocouple (TCN) ElectrodeGXI · Special | 03/08/2019SE |
| K183085 | CoreDx Pulmonary Mini-ForcepsEOQ · Traditional | 03/08/2019SE |
| K190184 | iSLEEVE Introducer SetDYB · Special | 03/07/2019SE |
| K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…FBN · Special | 01/22/2019SE |
| K182169 | AdVance XP Male SlingOTM · Traditional | 11/27/2018SE |
| K180068 | ORISE GelPLL · Traditional | 09/28/2018SE |
| K182315 | Magic Torque DLVR GuidewireDQX · Special | 09/26/2018SE |
| K180144 | Agile Esophageal Stent SystemESW · Traditional | 09/21/2018SE |
| K182275 | Seal Single Use Biopsy ValveOCX · Special | 09/13/2018SE |
| K181439 | SpyGlass DS and DS II Direct Visualization SystemFBN · Special | 08/23/2018SE |
| K173837 | RHYTHMIA HDx Mapping System (with software Version 2.0)DQK · Traditional | 07/25/2018SE |
| K180864 | WATCHMAN TruSeal Access SystemDQY · Traditional | 07/20/2018SE |
| K180785 | iSLEEVE Introducer SetDYB · Traditional | 06/22/2018SE |
| K180726 | Savion DLVR Guidewire, Savion FLX GuidewireDQX · Traditional | 06/18/2018SE |
| K181042 | Ultra ICE Plus PI 9 MHz Peripheral Imaging CatheterDXK · Special | 05/17/2018SE |
| K180102 | Embozene Color-Advanced MicrospheresNOY · Traditional | 04/19/2018SE |
| K180795 | JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireDQX · Special | 04/12/2018SE |
| K180530 | Imager II Urology Torque CatheterKOD · Special | 04/10/2018SE |
| K173400 | ORISE Tissue Retractor SystemFED · Traditional | 02/09/2018SE |
| K173820 | OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz…OBJ · Special | 01/17/2018SE |
| K172929 | Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal SheathLJE · Traditional | 01/10/2018SE |
| K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…PWJ · Traditional | 12/20/2017SE |
| K173251 | LumiCoil Platinum Fiducial MarkerIYE · Traditional | 12/19/2017SE |
| K171271 | Polyform Synthetic MeshOTO · Special | 12/15/2017SE |
| K173284 | OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz…OBJ · Special | 11/16/2017SE |
| K172453 | WATCHDOG Hemostasis Valve KitDQX · Traditional | 11/09/2017SE |
| K172591 | Fixed Patient Leads ECG Cable (Model 3153)DSA · Special | 11/03/2017SE |
| K172060 | Capio SLIM Suture Capturing DevicePWI · Traditional | 11/03/2017SE |
| K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleODG · Special | 10/27/2017SE |
| K172520 | CRE RX Biliary Balloon Dilatation CatheterFGE · Traditional | 10/04/2017SE |
| K171452 | MAMBA and MAMBA FLEX MicrocathetersDQY · Traditional | 08/21/2017SE |
| K171809 | Epic Biliary Endoscopic Stent SystemFGE · Traditional | 08/09/2017SESU |
| K171913 | Rubicon 14, 18 and 35 Support CathetersDQY · Special | 07/25/2017SE |
| K171454 | Interject Injection Therapy Needle CatheterFBK · Traditional | 07/07/2017SE |
| K170815 | PSA CableDTC · Traditional | 07/06/2017SE |
| K171612 | ACUITY Pro Lead Delivery SystemDQY · Special | 06/30/2017SE |
| K170759 | CRE Pulmonary Balloon Dilatation CatheterKTI · Special | 06/23/2017SE |
| K163399 | Tria Firm Ureteral StentFAD · Traditional | 06/22/2017SE |
| K163701 | Direxion and Direxion HI-FLO Torqueable MicrocathetersKRA · Special | 05/16/2017SE |
| K163248 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleEOQ · Traditional | 03/27/2017SE |
| K170204 | FFR Link, FFR Signal Processing ModuleDRG · Traditional | 03/24/2017SE |
| K163314 | Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension CatheterDQY · Traditional | 03/23/2017SE |
| K170636 | Fathom-16 Steerable GuidewiresDQX · Special | 03/22/2017SE |
| K162793 | RHYTHMIA HDx Mapping SystemDQK · Traditional | 03/10/2017SE |
| K163272 | AXIOS Stent and Electrocautery Enhanced Delivery SystemPCU · Traditional | 02/18/2017SE |
| K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleODG · Traditional | 01/30/2017SE |
| K163200 | Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteLOX · Special | 12/14/2016SE |
| K163174 | Emerge PTCA Dilatation CatheterLOX · Special | 12/14/2016SE |
| K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…LIT · Special | 11/04/2016SE |
| K162404 | Express SD Biliary Monorail Premounted Stent SystemFGE · Traditional | 10/12/2016SE |
| K160823 | NC Quantum Apex PTCA Dilatation CatheterLOX · Special | 06/23/2016SE |
| K160514 | OptiCross 18, 30 MHz Peripheral Imaging CatheterOBJ · Traditional | 06/22/2016SE |
| K161003 | EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector…PIF · Traditional | 06/17/2016SEKD |
| K160751 | Symphion Endoscope and Symphion Cervical SheathHIH · Traditional | 06/14/2016SE |
| K161125 | OptiCross X, 40 MHz Coronary Imaging CatheterOBJ · Special | 05/19/2016SE |
| K152842 | Wallstent RP Endoprosthesis Tracheobronchial, Wallstent Endoprosthesis TracheobronchialJCT · Traditional | 05/19/2016SE |
| K160845 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceODG · Special | 05/03/2016SE |
| K160637 | Rotatable SnaresFDI · Special | 03/30/2016SE |
| K160173 | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac…DXK · Special | 02/26/2016SE |
| K153617 | OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz…OBJ · Special | 02/25/2016SE |
| K152231 | Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireDQX · Traditional | 02/12/2016SE |
| K151840 | Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch…DQX · Traditional | 12/16/2015SE |
| K153088 | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery…PCU · Traditional | 12/11/2015SE |
| K152401 | Stingray LP CatheterDQY · Traditional | 12/04/2015SE |
| K152853 | WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic…FGE · Traditional | 11/20/2015SE |
| K153049 | LithoVue SystemFGB · Traditional | 11/13/2015SE |
| K151315 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleEOQ · Traditional | 11/10/2015SE |
| K152605 | Impulse Angiographic Catheter, Expo Angiographic CatheterDQO · Special | 10/29/2015SE |
| K152607 | Express SD Biliary Monorail Premounted Stent SystemFGE · Traditional | 10/27/2015SE |
| K151895 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleFCG · Traditional | 10/22/2015SE |
| K152693 | CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II…DRQ · Special | 10/21/2015SE |
| K152572 | AXIOS Stent and Delivery SystemPCU · Special | 10/06/2015SE |
| K151613 | iLab Polaris Multi-Modality Guidance SystemDQK · Traditional | 10/06/2015SE |
| K151610 | Comet Pressure GuidewireDXO · Traditional | 10/06/2015SE |
| K152403 | Permanent Sled BagITX · Special | 09/22/2015SE |
| K151313 | ZelanteDVT Thrombectomy SetQEW · Traditional | 09/21/2015SE |
| K152316 | iLab Ultrasound Imaging SystemIYO · Special | 09/18/2015SE |
| K151802 | Resolution ClipPKL · Traditional | 08/06/2015SE |
| K150692 | AXIOS Stent with Electrocautery Enhanced Delivery SystemPCU · Traditional | 08/05/2015SE |
| K143193 | Symmetry and Symmetry Stiff Shaft Balloon Dilatation CathetersLIT · Traditional | 07/24/2015SE |
| K150303 | XXL Vascular Balloon Dilatation CatheterLIT · Traditional | 06/15/2015SE |
| K151253 | 2cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterPNO · Special | 06/10/2015SE |
| K150186 | Chariot Guiding SheathDYB · Traditional | 06/05/2015SE |
| K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial…PIF · Traditional | 05/29/2015SEKD |
| K150235 | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II…DRQ · Special | 04/22/2015SE |
| K142922 | SpyGlass DS Direct Visualization SystemFBN · Traditional | 01/16/2015SE |
| K143587 | ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…DQX · Special | 01/15/2015SE |
| K142973 | Resolution ClipPKL · Traditional | 12/01/2014SE |
| K141820 | Jagwire High Performance GuidwireOCY · Traditional | 10/21/2014SE |
| K141344 | Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage…FAD · Traditional | 10/17/2014SE |
| K141335 | Expel Apd Drainage Catheter SystemFGE · Traditional | 10/17/2014SE |
| K141584 | Ultraflex Tracheobronchial Covered Stent SystemJCT · Traditional | 10/16/2014SE |
| K141378 | Idc Interlocking Detachable CoilKRD · Traditional | 10/08/2014SE |
| K141150 | Pta Balloon Dilatation CatheterLIT · Traditional | 09/25/2014SE |
| K142259 | Direxion Torqueable MicrocatheterKRA · Special | 09/10/2014SE |
| K141597 | Mustang Balloon Dialation CatheterFGE · Special | 08/22/2014SE |
| K141521 | Mustang Balloon Dilatation Catheter/Charger Pta Balloon Dilatation CatheterLIT · Special | 08/21/2014SE |
| K141236 | NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter…LOX · Traditional | 08/07/2014SE |
| K140273 | Equalizer Occlusion Balloon CatheterMJN · Traditional | 07/22/2014SE |
| K140726 | Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator Emr Device for…FDI · Traditional | 07/21/2014SE |
| K134031 | Threader Monorail Micro-Dilatation Catheter, Threader Over-The-Wire Micro-Dilatation…LOX · Traditional | 07/21/2014SE |
| K141112 | Sterling Over-The Wire Pta Balloon Dilatation CatheterLIT · Special | 07/16/2014SE |
| K140641 | Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, LimaDYB · Traditional | 07/03/2014SE |
| K133110 | Express LD Biliary Premounted Stent SystemFGE · Traditional | 07/02/2014SESU |
| K141185 | V2.7 Software for the Labsystem Pro Ep Recording SystemDQK · Special | 06/06/2014SE |
| K140630 | Wallflex Biliary RX Stent SystemFGE · Traditional | 05/23/2014SESU |
| K140329 | Renegade Hi-Flo Microcatheter, Microcatheter Kit, Fathom System, Fathom KitKRA · Special | 05/15/2014SE |
| K133700 | Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and…FGE · Traditional | 05/14/2014SE |
| K140733 | Constellation Multiple Electrode Recording & Pacing CatheterMTD · Traditional | 04/28/2014SE |
| K140745 | Encore 26 Advantage KitMAV · Special | 04/17/2014SESK |
| K140495 | Leveen Standard Needle Electrode, Leveen Coaccess Needle ElectrodeGEI · Traditional | 04/17/2014SE |
| K140673 | Insertion ToolDQX · Special | 04/16/2014SE |
| K140288 | Truepath Cto DevicePDU · Special | 04/16/2014SE |
| K140503 | Flexiva SF Side-Firing Single-Use Laser FiberGEX · Traditional | 04/15/2014SE |
| K132914 | Acuity Pro Lead Delivery SystemDQY · Traditional | 04/03/2014SE |
| K133933 | Injection Gold Probe Bipolar Electrohemostasis CatheterKNS · Special | 04/02/2014SE |
| K140323 | Navigator HD Ureteral Access Sheath SetsFED · Special | 03/07/2014SE |
| K132810 | Gladiator Elite Pta Balloon Dilatation CatheterLIT · Traditional | 02/28/2014SE |
| K133987 | Captivator Ii,Single-Use Polypectomy SnaresFDI · Special | 01/24/2014SE |
| K133750 | Occluder Occlusion Balloon CatheterEYB · Traditional | 01/08/2014SE |
| K133312 | Expect Slimline Endoscopic Ultrasound Aspiration NeedleODG · Special | 01/03/2014SE |
| K133566 | Rotablator Rotational Atherectomy System with the Peripheral Rotalink PlusMCW · Special | 12/20/2013SE |
| K132253 | Removable Patient Leads ECG CableDSA · Traditional | 12/16/2013SE |
| K130004 | Ultraflex Esophageal NG Stent SystemESW · Traditional | 12/06/2013SE |
| K133208 | INTERLOCK-35 Fibered Idc Occlusion SystemKRD · Special | 11/14/2013SE |
| K131700 | Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use…FDI · Traditional | 11/04/2013SE |
| K131914 | Offroad Re-Entry Catheter SystemPDU · Traditional | 10/31/2013SE |
| K132990 | Occlusion Balloon CatheterMJN · Special | 10/22/2013SE |
| K132947 | Direxion and Direxion Hi-Flo Torqueable MicrocathetersKRA · Special | 10/18/2013SE |
| K132430 | Sterling Over-The-Wire (Otw) Pta Balloon Dilatation CatheterLIT · Traditional | 10/17/2013SE |
| K132578 | Interlock - 18 Fibered Idc Occlusion SystemKRD · Special | 09/13/2013SE |
| K130484 | Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary CatheterFGE · Special | 08/09/2013SE |
| K130391 | Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter…LOX · Traditional | 07/10/2013SE |
| K130382 | Heartstring III Proximal Seal SystemDXC · Traditional | 06/05/2013SE |
| K130804 | Uromax Ultra Balloon Dilatation CatheterEZN · Traditional | 05/22/2013SE |
| K130909 | Gateway Advanage Y-AdapterOCX · Traditional | 05/16/2013SE |
| K123621 | Opticross 40 MHZ Coronary Imaging CatheterOBJ · Traditional | 04/15/2013SE |
| K130121 | Short Port Blunt Tip TrocarGCJ · Traditional | 04/11/2013SE |
| K123765 | Guidezilla Guide Extension CatheterDQY · Traditional | 03/19/2013SE |
| K130243 | Ilab Ultrasound Imaging SystemIYO · Special | 03/01/2013SE |
| K123424 | MDU5 Plus Sterile BagITX · Traditional | 02/20/2013SE |
| K123535 | Ilab Ultrasound Imaging SystemIYO · Special | 01/15/2013SE |
| K122794 | Upsylon Y MeshOTO · Traditional | 12/18/2012SE |
| K122459 | Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemOTP · Abbreviated | 12/13/2012SE |
| K122649 | Navigator HD Ureteral Access Sheath SetFED · Traditional | 12/12/2012SE |
| K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612PKL · Traditional | 12/03/2012SE |
| K123214 | Encore 26 Advantage KitMAV · Special | 11/13/2012SE |
| K123024 | Torque DeviceDQX · Special | 10/26/2012SE |
| K122924 | Cre Fixed Wire Ballon Dilation CatheterKNQ · Special | 10/24/2012SE |
| K121754 | Blue Sui SlingOTN · Traditional | 10/10/2012SE |
| K122072 | Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered)…FGE · Traditional | 09/28/2012SESU |
| K121614 | Nephromax High Pressure Nephrostomy Baloon Dilatation CatheterLJE · Traditional | 09/18/2012SE |
| K121694 | Imager II Angiographic CatheterDQO · Traditional | 09/14/2012SE |
| K121774 | Rotablator Rotational Atherectomy System with Peripheral Rotalink PlusMCW · Traditional | 09/13/2012SE |
| K121196 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-The-Wire)LOX · Traditional | 08/31/2012SE |
| K122394 | Rubicon 18 Support CatheterDQY · Special | 08/30/2012SE |
| K122203 | TruetomeKNS · Special | 08/17/2012SE |
| K121667 | NC Quantum Apex Ptca Dilatation Catheter (Monorail)LOX · Special | 08/13/2012SE |
| K121048 | Ultraflex Tracheobronchial Stent System- Sterile UncoveredJCT · Traditional | 08/03/2012SE |
| K120495 | Impulse and Expo Angiographic CatheterDQO · Special | 05/21/2012SE |
| K121186 | Radial Jaw 4 Pulmonary Biopsy ForcepsBWH · Special | 05/16/2012SE |
PMA approvals
- P130030 Rebel Platinum Chromium Coronary Stent System Monorail and Over the Wire · 03/10/2026 · 75 supplements
- P230035 AGENT Paclitaxel-Coated Balloon Catheter · 02/29/2024 · 8 supplements
- P220032 POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories · 08/08/2023 · 12 supplements
- P200036 eCoin Peripheral Neurostimulator · 03/01/2022 · 10 supplements
- P200029 TheraSphere · 03/17/2021 · 13 supplements
- P190019 Ranger Paclitaxel-Coated PTA Balloon Catheter · 10/30/2020 · 41 supplements
- P170023 Bulkamid Urethral Bulking System · 01/28/2020 · 21 supplements
- P180046 Axonics Sacral Neuromodulation System · 11/13/2019 · 103 supplements
- P190006 Axonics Sacral Neuromodulation System · 09/06/2019 · 103 supplements
- P180013 VICI VENOUS STENT System · 05/02/2019 · 7 supplements
- P180029 LOTUS Edge Valve System · 04/23/2019 · 28 supplements
- P180011 Eluvia Drug-Eluting Vascular Stent System · 09/18/2018 · 67 supplements
- P150031 Vercise Deep Brain Stimulation (Dbs)System · 12/08/2017 · 92 supplements
- P150012 Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead · 04/25/2016 · 183 supplements
- P150005 Blazer Open-Irrigated Ablation Catheter · 02/24/2016 · 91 supplements
- P150003 Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System · 10/02/2015 · 109 supplements
- P140008 Orbera Intragastric Balloon · 08/05/2015 · 23 supplements
- P140012 Reshape Integrated Dual Balloon System · 07/28/2015 · 13 supplements
- P140028 Innova Vascular Self-Expanding Stent with Delivery System · 07/21/2015 · 86 supplements
- P140026 Enroute Transcarotid Stent System · 05/18/2015 · 31 supplements
- P130013 Watchman Left Atrial Appendage (Laa) Closure Technology · 03/13/2015 · 84 supplements
- P110042 Subcutaneous Implantable Defibrillator (S-Icd) System · 09/28/2012 · 205 supplements
- P110035 Epic Self-Expanding Nitinol Stent System · 04/13/2012 · 76 supplements
- P110010 Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System · 11/22/2011 · 207 supplements
- P100023 Ion Paclitaxel- Eluting Coronary Stent System (Monorail and Over-The-Wire Systems) · 04/22/2011 · 118 supplements
- P080032 Alair Bronchial Thermoplasty System · 04/27/2010 · 20 supplements
- P090003 Express LD Iliac Premounted Stent System · 03/05/2010 · 53 supplements
- P060006 Boston Scientific Express SD Renal Monorail Premounted Stent System · 12/11/2008 · 104 supplements
- P050019 Carotid Wallstent Monorail Endoprosthesis · 10/23/2008 · 41 supplements
- P060008 Taxus Liberte Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire) · 10/10/2008 · 103 supplements
- P050024 Cryocor Cryoablation System · 08/01/2007 · 1 supplement
- P050025 Endotex Nexstent Carotid Stent and Delivery System and Endotex Carotid Stent and Monorail Delivery System · 10/27/2006 · 6 supplements
- P030017 Precision Spinal Cord Stimulation(Scs) System · 04/27/2004 · 372 supplements
- P030025 Taxus EXPRESS2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire) · 03/04/2004 · 98 supplements
- P020025 Ep Technologies EPT-1000 XP RF Ablation System · 08/25/2003 · 141 supplements
- P020006 Enteryx Procedure Kit · 04/22/2003 · 4 supplements
- P010012 Contak Cd,Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrilll · 05/02/2002 · 578 supplements
- P010020 Ams Acticon Neosphincter · 12/18/2001 · 32 supplements
- P980033 Wallstent Endoprosthesis · 11/16/2001 · 65 supplements
- P000043 TMX-2000 BPH Thermotherapy System · 06/29/2001 · 20 supplements
- P000053 Ams Sphincter 800 Urinary Control System · 06/14/2001 · 134 supplements
- P000020 Stinger Ablation Catheter; Templink Extension Cable · 11/29/2000 · 18 supplements
- P950020 Flexatome Cutting Balloon · 04/18/2000 · 139 supplements
- P990054 Chilli Cooled Ablation System · 03/17/2000 · 7 supplements
- P990017 Ancure(Tm) Tube System, Ancure(Tm) Bifurcated System · 09/28/1999 · 33 supplements
- N970003 Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software · 06/03/1999 · 159 supplements
- P980037 Angiojet Rheolytic Thrombectomy LF140 Catheter · 03/12/1999 · 93 supplements
- P980003 Chilli Cooled RF Ablation System · 02/02/1999 · 90 supplements
- N970012 Ams 700 Series Product Line and the Dynaflex Inflatable Penile Prostheses · 11/02/1998 · 130 supplements
- P960006 Sweet Tip(R) RX Steroid Eluting Lead · 10/02/1998 · 52 supplements
- P980001 Nir on TM Ranger TM Premounted Stent System · 08/11/1998 · 38 supplements
- P960040 Ventak Av Aicd Ventak Prizm Dr/Vr, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator System · 07/18/1997 · 485 supplements
- P960004 Thinline Endocardial Pacing Leads · 11/12/1996 · 103 supplements
- P950001 Selute Steroid Eluting Endocardial Lead Models 4185 & 4285 · 05/08/1996 · 27 supplements
- P920023 Urolume Endoprosthesis · 05/06/1996 · 30 supplements
- P940008 Res-Q(Tm) Arrhythmia Control Device Epicardial Patch and Non-Thoracotomy Lead (NTL) Systems · 11/28/1995 · 27 supplements
- P930031 Wallstent(R) Tips Endoprosthesis with Unistep Plus Delivery System · 09/29/1995 · 72 supplements
- P940031 Vigor(Tm) DR Pacemaker System · 06/21/1995 · 75 supplements
- P930035 Ventak(R) P2 System · 03/10/1995 · 36 supplements
- P920047 EPT-1000 Cardiac Ablation System · 10/28/1994 · 133 supplements
- P910077 Ventak(R) PRX (TM) Model 1700,1705 Pulse Generator · 06/17/1994 · 184 supplements
- P910073 Endotak Lead System · 08/26/1993 · 178 supplements
- P900056 Rotablator(R) · 05/28/1993 · 216 supplements
- P910020 Relay(Tm) Models 294-03 & 293-03 & Dash Models · 06/15/1992 · 26 supplements
- P890061 Ventak P 1600 Aicd and 2830 Software Module · 05/02/1991 · 22 supplements
- P880055 Coronary Balloon Dilatation Catheter · 09/26/1990 · 2 supplements
- P880065 Mansfield Sci. Aortic Valvuloplasty Catheter · 09/19/1990 · 8 supplements
- P880027 Microsoftrac TM (Ptca) Catheter · 04/14/1989 · 60 supplements
- P860007 Intertach TM Implantable Pacemaker Pulse · 12/31/1986 · 23 supplements
- P840040 Medi-Tech Coronary Balloon Dilatation Catheter Sys · 12/19/1985 · 49 supplements
- P840068 Delta Pacemaker Sys; Vigor DDD Model 950 · 11/27/1985 · 54 supplements
- P830060 Ventak and Automatic Implantable Cardioverter Defibrillator (Aicd) Systems · 10/04/1985 · 85 supplements
- P820022 Cybertach(Tm) 60 Pulse Generator & Programmer · 11/07/1984 · 5 supplements
- P830026 Cosmos(Tm) System · 03/23/1984 · 78 supplements
- P800019 Cyberlith IV Unipolar Pulse Generator · 03/06/1981 · 12 supplements
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-3214-2026 | Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER…Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through… | 08/24/2026Open, Classified |
| Z-3083-2026 Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY…There is potential for a delay in AF Burden Alert notification affecting the server software which supports… | 08/06/2026Open, Classified |
| Z-3082-2026 Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY…There is potential for a delay in AF Burden Alert notification affecting the server software which supports… | 08/06/2026Open, Classified |
| Z-3081-2026 Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY…There is potential for a delay in AF Burden Alert notification affecting the server software which supports… | 08/06/2026Open, Classified |
| Z-3188-2026 | Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1)…A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the… | 07/22/2026Open, Classified |
| Z-2962-2026 Class II | Suture Cinch Long 1pk. Endoscopic tissue approximation device.Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | 07/14/2026Open, Classified |
| Z-2961-2026 Class II | OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | 07/14/2026Open, Classified |
| Z-2978-2026 Class I | Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number…Potential for arterial sheath tip separation or partial tip separation during use. | 07/09/2026Open, Classified |
| Z-2977-2026 Class I | Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number…Potential for arterial sheath tip separation or partial tip separation during use. | 07/09/2026Open, Classified |
| Z-2840-2026 Class II | Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4…Potential for breach in sterile barrier of device packaging. | 06/30/2026Open, Classified |
| Z-2839-2026 Class II | Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1.…Potential for breach in sterile barrier of device packaging. | 06/30/2026Open, Classified |
| Z-2838-2026 Class II | Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:…Potential for breach in sterile barrier of device packaging. | 06/30/2026Open, Classified |
| Z-2725-2026 Class II | Rapid Refill Continuous Injection System, UPN M00566001Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk… | 06/30/2026Open, Classified |
| Z-2771-2026 Class II | Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001…Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the… | 06/19/2026Open, Classified |
| Z-2757-2026 Class II | FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | 06/11/2026Open, Classified |
| Z-2756-2026 Class II | FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | 06/11/2026Open, Classified |
| Z-2755-2026 Class II | FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | 06/11/2026Open, Classified |
| Z-2754-2026 Class II | FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | 06/11/2026Open, Classified |
| Z-2753-2026 Class II | FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401…Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not… | 06/11/2026Open, Classified |
| Z-2752-2026 Class II | FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation CatheterLabeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA… | 06/11/2026Open, Classified |
| Z-2751-2026 Class II | FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous…Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA… | 06/11/2026Open, Classified |
| Z-2750-2026 Class II | FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401…Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA… | 06/11/2026Open, Classified |
| Z-2637-2026 Class II | CRE Wireguided 18-20mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2636-2026 Class II | CRE Wireguided 15-18mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2635-2026 Class II | CRE Wireguided 12-15mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2634-2026 Class II | CRE Wireguided 10-12mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2633-2026 Class II | CRE Wireguided 8-10mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2632-2026 Class II | CRE Wireguided 6-8mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2631-2026 Class II | CRE Pro Wireguided 18-20mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2630-2026 Class II | CRE Pro Wireguided 15-18mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2629-2026 Class II | CRE Pro Wireguided 12-15mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2628-2026 Class II | CRE Pro Wireguided 10-12mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2627-2026 Class II | CRE Pro Wireguided 8-10mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2626-2026 Class II | CRE Pro Wireguided 6-8mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2413-2026 Class II | Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca…Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction… | 05/12/2026Open, Classified |
| Z-2580-2026 Class II | Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug…There is the potential for leakage along the drug pathway from the pump through the end of the catheter. | 05/11/2026Completed |
| Z-2049-2026 Class II | LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON…For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not… | 03/30/2026Open, Classified |
| Z-2048-2026 Class II | LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US…For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not… | 03/30/2026Open, Classified |
| Z-1771-2026 Class I | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P…Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of… | 03/19/2026Open, Classified |
| Z-1770-2026 Class I | Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac…Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of… | 03/19/2026Open, Classified |
| Z-1551-2026 Class II | EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material…Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile… | 02/10/2026Open, Classified |
| Z-1163-2026 Class I | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | 12/19/2025Open, Classified |
| Z-1162-2026 Class I | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | 12/19/2025Open, Classified |
| Z-1161-2026 Class I | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | 12/19/2025Open, Classified |
| Z-1160-2026 Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | 12/19/2025Open, Classified |
| Z-1159-2026 Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | 12/19/2025Open, Classified |
| Z-1158-2026 Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | 12/19/2025Open, Classified |
| Z-1042-2026 Class II | Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm…Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous… | 12/03/2025Open, Classified |
| Z-0144-2026 Class II | LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ)…The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-0143-2026 Class II | CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ)…The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-0142-2026 Class II | CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ)…The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-0141-2026 Class II | LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2)…The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-0140-2026 Class II | CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2)…The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-0139-2026 Class II | TENACIO Pump without InhibiZone; UPN: 72404420;The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-0138-2026 Class II | TENACIO Pump with InhibiZone; UPN: 72404429;The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-2618-2025 Class II | Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below)…The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon… | 08/28/2025Open, Classified |
| Z-0105-2026 Class I | Model Number U228, VISIONIST CRT-P EL MRISoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0104-2026 Class I | Model Number U226, VISIONIST CRT-P ELSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0103-2026 Class I | Model Number U225 VISIONIST CRT-P ELSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0102-2026 Class I | Model Number U128, VALITUDE CRT-P EL MRISoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0101-2026 Class I | Model Number U125, VALITUDE CRT-P ELSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0100-2026 Class I | Model Number S722, ALTRUA 2 DR EL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0099-2026 Class I | Model Number S702, ALTRUA 2 DR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0098-2026 Class I | Model Number S701 ALTRUA 2 SR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0097-2026 Class I | Model Number L131, ESSENTIO DR EL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0096-2026 Class I | Model Number L121 ESSENTIO DR EL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0095-2026 Class I | Model Number L111, ESSENTIO DR SL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0094-2026 Class I | Model Number L110, ESSENTIO SR SL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0093-2026 Class I | Model Number L101, ESSENTIO DR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0092-2026 Class I | Model Number L100, ESSENTIO SR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0091-2026 Class I | Model Number L231, PROPONENT DR EL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0090-2026 Class I | Model Number L221 PROPONENT DR EL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0089-2026 Class I | Model Number L211 PROPONENT DR SL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0088-2026 Class I | Model Number L210 PROPONENT SR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0087-2026 Class I | Model Number L209 PROPONENT DR (VDD) SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0086-2026 Class I | PROPONENT DR SL (Model L201)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0085-2026 Class I | PROPONENT SR SL (Model L200)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0084-2026 Class I | ACCOLADE DR EL MRI (Model L331)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0083-2026 Class I | ACCOLADE DR EL (Model L321)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0082-2026 Class I | ACCOLADE DR SL MRI (Model L311)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0081-2026 Class I | ACCOLADE SR SL MRI (Model L310)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0080-2026 Class I | ACCOLADE DR SL (Model L301)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-0079-2026 Class I | ACCOLADE SR SL (Model L300)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | 08/20/2025Open, Classified |
| Z-2551-2025 Class II | Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | 08/18/2025Open, Classified |
| Z-2550-2025 Class II | ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material…Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | 08/18/2025Open, Classified |
| Z-2536-2025 Class II | Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2.…The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the… | 08/05/2025Open, Classified |
| Z-2535-2025 Class II | Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600.…The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the… | 08/05/2025Open, Classified |
| Z-2534-2025 Class II | Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2.…The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the… | 08/05/2025Open, Classified |
| Z-2533-2025 Class II | Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011…The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the… | 08/05/2025Open, Classified |
| Z-2436-2025 Class I | WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | 07/29/2025Open, Classified |
| Z-2435-2025 Class I | WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | 07/29/2025Open, Classified |
| Z-2434-2025 Class I | WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | 07/29/2025Open, Classified |
| Z-2433-2025 Class I | WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | 07/29/2025Open, Classified |
| Z-2432-2025 Class I | WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | 07/29/2025Open, Classified |
| Z-2431-2025 Class I | WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | 07/29/2025Open, Classified |
| Z-2430-2025 Class I | WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | 07/29/2025Open, Classified |
| Z-2429-2025 Class I | WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | 07/29/2025Open, Classified |
| Z-2428-2025 Class I | WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | 07/29/2025Open, Classified |
| Z-2427-2025 Class I | WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | 07/29/2025Open, Classified |
| Z-2426-2025 Class I | WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | 07/29/2025Open, Classified |
| Z-2327-2025 Class I | RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead…Affected lead models may experience gradually rising LVSI measurements in association with calcification of… | 07/24/2025Open, Classified |
| Z-2326-2025 Class I | ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent…Affected lead models may experience gradually rising LVSI measurements in association with calcification of… | 07/24/2025Open, Classified |
| Z-2325-2025 Class I | ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter…Affected lead models may experience gradually rising LVSI measurements in association with calcification of… | 07/24/2025Open, Classified |
| Z-2273-2025 Class I | Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and…Certain batches are being removed due to an increase in complaints received in which physicians encountered… | 07/07/2025Open, Classified |
| Z-2278-2025 Class II | FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401The potentially impacted units were manufactured using specific equipment that may have caused cracks in the… | 06/25/2025Open, Classified |
| Z-2106-2025 Class II | Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG…Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.… | 06/10/2025Open, Classified |
| Z-2105-2025 Class II | VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS…Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.… | 06/10/2025Open, Classified |
| Z-2104-2025 Class II | VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the…Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.… | 06/10/2025Open, Classified |
| Z-2103-2025 Class II | VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE…Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.… | 06/10/2025Open, Classified |
| Z-1689-2025 Class II | IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are…Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025… | 03/24/2025Open, Classified |
| Z-1688-2025 Class II | IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are…Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025… | 03/24/2025Open, Classified |
| Z-1687-2025 Class II | IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are…Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025… | 03/24/2025Open, Classified |
| Z-1686-2025 Class II | IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are…Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025… | 03/24/2025Open, Classified |
| Z-1037-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1036-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1035-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1034-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1033-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1032-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1031-2025 Class II | AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1030-2025 Class II | AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1029-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1028-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1027-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1026-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1025-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1024-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-0827-2025 Class I | VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an… | 12/12/2024Open, Classified |
| Z-0826-2025 Class I | VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an… | 12/12/2024Open, Classified |
| Z-0825-2025 Class I | ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an… | 12/12/2024Open, Classified |
| Z-0824-2025 Class I | ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model…A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an… | 12/12/2024Open, Classified |
| Z-0823-2025 Class I | PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI…A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an… | 12/12/2024Open, Classified |
| Z-0822-2025 Class I | ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model…A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an… | 12/12/2024Open, Classified |
| Z-0531-2025 Class II | AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2OPotential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024)… | 10/28/2024Open, Classified |
| Z-0530-2025 Class II | AMS Artificial Urinary Sphincter Control PumpPotential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024)… | 10/28/2024Open, Classified |
| Z-0303-2025 Class I | Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000…Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0302-2025 Class I | Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0301-2025 Class I | Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0300-2025 Class I | Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0299-2025 Class I | Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0298-2025 Class I | Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0297-2025 Class I | Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0226-2025 Class II | Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number…Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not… | 09/06/2024Open, Classified |
| Z-0116-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0115-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0114-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0113-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0112-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0111-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0110-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0109-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0108-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0107-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0106-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU +…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0105-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL -…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0104-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0103-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0102-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0101-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0100-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0099-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0098-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0097-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0096-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-0095-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | 09/05/2024Open, Classified |
| Z-3295-2024 Class II | AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3294-2024 Class II | AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3293-2024 Class II | AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3292-2024 Class II | AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3291-2024 Class II | AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3290-2024 Class II | AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3289-2024 Class II | AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3288-2024 Class II | AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3287-2024 Class II | AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3286-2024 Class II | WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3285-2024 Class II | WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3284-2024 Class II | WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3283-2024 Class II | WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3282-2024 Class II | WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3281-2024 Class II | WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3280-2024 Class II | WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3279-2024 Class II | WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3278-2024 Class II | WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3277-2024 Class II | WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3276-2024 Class II | WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3275-2024 Class II | WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3274-2024 Class II | WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3273-2024 Class II | WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3272-2024 Class II | WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3271-2024 Class II | WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3270-2024 Class II | WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3269-2024 Class II | WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3268-2024 Class II | WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3267-2024 Class II | WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3266-2024 Class II | WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3265-2024 Class II | WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully…WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the… | 08/01/2024Open, Classified |
| Z-3151-2024 Class II | VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to…There is the potential for holes in the clear sterile barrier of the device pouch which may impact device… | 07/18/2024Open, Classified |
| Z-3150-2024 Class II | vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number…There is the potential for holes in the clear sterile barrier of the device pouch which may impact device… | 07/18/2024Open, Classified |
| Z-3149-2024 Class II | Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To…There is the potential for holes in the clear sterile barrier of the device pouch which may impact device… | 07/18/2024Open, Classified |
| Z-3148-2024 Class II | Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile…There is the potential for holes in the clear sterile barrier of the device pouch which may impact device… | 07/18/2024Open, Classified |