Abbott Medical
Medical device manufacturer in St. Paul, MN.
59510(k) clearances
32PMA approvals
43recalls
Device types
- DQK Computer, Diagnostic, Programmable 13
- DQY Catheter, Percutaneous 13
- DYB Introducer, Catheter 4
- DQO Catheter, Intravascular, Diagnostic 3
- NQQ System, Imaging, Optical Coherence… 3
- OWQ Reprocessed Intravascular Ultrasound Catheter 3
- DQX Wire, Guide, Catheter 3
- GXD Generator, Lesion, Radiofrequency 2
- QEZ Aspiration Thrombectomy Catheter 2
- GXI Probe, Radiofrequency Lesion 2
- OBJ Catheter, Ultrasound, Intravascular 2
- MXC Recorder, Event, Implantable Cardiac… 1
- LIT Catheter, Angioplasty, Peripheral… 1
- MXD Recorder, Event, Implantable Cardiac, (With… 1
- KRH Ring, Annuloplasty 1
- MTD Catheter, Intracardiac Mapping… 1
- QNR Blood Pump For Ecmo, Long-Term (> 6 Hours)… 1
- DRA Catheter, Steerable 1
- MMX Device, Percutaneous Retrieval 1
- DRF Catheter, Electrode Recording, Or Probe… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262006 | EnSite X EP SystemDQK · Special | 07/15/2026SE |
| K261631 | Amplatzer TorqVue Exchange SystemDQY · Special | 06/17/2026SE |
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…NQQ · Traditional | 04/24/2026SE |
| K260212 | EnSite X EP SystemDQK · Traditional | 04/20/2026SE |
| K253907 | Disposable Radiofrequency CannulaGXI · Traditional | 04/16/2026SE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/…DQY · Special | 03/13/2026SE |
| K252512 | Armada 14 NC PTA CatheterLIT · Traditional | 02/13/2026SE |
| K253516 | Assert-IQ (DM5100)MXD · Special | 12/18/2025SE |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045)DQY · Traditional | 12/17/2025SE |
| K253232 | Seguin Annuloplasty RingKRH · Special | 10/29/2025SE |
| K250031 | Amplatzer GuidewireDQX · Traditional | 10/03/2025SE |
| K252013 | EnSite X EP SystemDQK · Traditional | 09/25/2025SE |
| K251463 | EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP…DQK · Special | 09/04/2025SE |
| K251234 | EnSite X EP SystemDQK · Traditional | 07/30/2025SE |
| K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireDQX · Traditional | 07/25/2025SE |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)GXI · Traditional | 05/27/2025SE |
| K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid…OBJ · Special | 05/23/2025SE |
| K251231 | ViewFlex X ICE Catheter, Sensor EnabledOBJ · Special | 05/20/2025SE |
| K250426 | Amulet Steerable Delivery SheathDQY · Special | 04/25/2025SE |
| K243549 | JETi Hydrodynamic Thrombectomy SystemQEZ · Traditional | 04/04/2025SE |
| K243224 | MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter…DQY · Traditional | 12/31/2024SE |
| K243493 | Agilis NxT Steerable Introducer Dual-ReachDYB · Special | 12/13/2024SE |
| K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireDQX · Traditional | 11/06/2024SE |
| K241538 | TriClip Steerable Guide CatheterDQY · Traditional | 08/26/2024SE |
| K242016 | EnSite X EP SystemDQK · Special | 08/09/2024SE |
| K241372 | Advisor HD Grid X Mapping Catheter, Sensor EnabledMTD · Special | 07/09/2024SE |
| K241370 | Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)DYB · Special | 06/13/2024SE |
| K234118 | CentriMag Acute Circulatory Support SystemQNR · Special | 01/26/2024SE |
| K232458 | JETiHydrodynamic Thrombectomy SystemQEZ · Traditional | 12/19/2023SE |
| K232690 | Amulet Steerable Delivery SheathDQY · Special | 09/29/2023SE |
| K232386 | ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue…NQQ · Special | 09/08/2023SE |
| K231415 | EnSite X EP SystemDQK · Traditional | 08/10/2023SE |
| K231588 | ViewFlex Eco Reprocessed ICE CatheterOWQ · Special | 06/30/2023SE |
| K231311 | CPS Direct Universal slittable outer guide catheter (DS2C029)DQY · Special | 06/02/2023SE |
| K230286 | Assert-IQ Insertable Cardiac MonitorMXC · Traditional | 05/17/2023SE |
| K230934 | ViewFlex Eco Reprocessed ICE CatheterOWQ · Special | 05/03/2023SE |
| K230411 | Dragonfly OpStar Imaging CatheterDQO · Traditional | 04/14/2023SE |
| K230283 | Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122…DYB · Special | 03/01/2023SE |
| K223094 | EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade…DQK · Traditional | 12/27/2022SE |
| K222217 | ViewFlex Xtra Reprocessed ICE CatheterOWQ · Traditional | 12/19/2022SE |
| K221397 | MitraClip G4 Steerable Guide CatheterDRA · Special | 09/28/2022SE |
| K221750 | CPS AIM Universal II Slittable Inner CatheterDQY · Special | 06/30/2022SE |
| K220243 | Ultiri Measurement SystemDQK · Traditional | 04/30/2022SE |
| K213494 | Aveir Retrieval CatheterMMX · Traditional | 04/01/2022SE |
| K220340 | Amplatzer Steerable Delivery SheathDQY · Special | 03/09/2022SE |
| K203293 | Abbott Medical Grounding Pad, model RF-DGP-ISGXD · Traditional | 01/21/2022SE |
| K213364 | EnSite X EP SystemDQK · Special | 11/11/2021SE |
| K212738 | Amplatzer Talisman Delivery SheathDQY · Special | 09/27/2021SE |
| K212026 | Amplatzer Steerable Delivery SheathDQY · Traditional | 09/27/2021SE |
| K211989 | Aveir IntroducerDYB · Special | 07/27/2021SE |
| K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemNQQ · Traditional | 06/08/2021SE |
| K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…DQK · Traditional | 11/25/2020SE |
| K201610 | IonicRF GeneratorGXD · Traditional | 10/21/2020SE |
| K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemDQK · Traditional | 06/26/2020SE |
| K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation…DQK · Traditional | 06/26/2020SE |
| K192267 | ILUMIEN System with AptiVue Software version D.3DQO · Special | 12/17/2019SE |
| K192019 | Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1DQO · Traditional | 11/08/2019SE |
| K192037 | Advisor VL Circular Mapping Catheter, Sensor EnabledDRF · Traditional | 09/17/2019SE |
| K190581 | Amplatzer Trevisio Intravascular Delivery SystemDQY · Special | 04/05/2019SE |
PMA approvals
- P250022 Volt PFA System · 12/19/2025 · 7 supplements
- P240042 Tendyne Transcatheter Mitral Valve System · 05/23/2025 · 4 supplements
- P230036 Esprit BTK Everolimus Eluting Resorbable Scaffold System · 04/26/2024 · 18 supplements
- P230007 TriClip G4 System · 04/01/2024 · 22 supplements
- P220013 TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C · 05/18/2023 · 31 supplements
- P150035 Aveir VR Leadless System · 03/31/2022 · 41 supplements
- P190023 Portico Transcatheter Aortic Valve Implantation System · 09/17/2021 · 32 supplements
- P200049 Amplatzer Amulet Left Atrial Appendage Occluder · 08/14/2021 · 19 supplements
- P160054 HeartMate 3 Left Ventricular Assist System · 08/23/2017 · 130 supplements
- P140033 Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software · 01/31/2017 · 100 supplements
- P120021 Amplatzer Pfo Occluder · 10/28/2016 · 26 supplements
- P150004 Axium Neurostimulator System · 02/11/2016 · 91 supplements
- P140009 Brio Neurostimulation System · 06/12/2015 · 134 supplements
- P100045 Cardiomems HF Pressure Measurement System · 05/28/2014 · 88 supplements
- P100009 Mitraclip Delivery System · 10/24/2013 · 82 supplements
- P110016 Therapy Cool Path Duo/ Safire Blu Duo Ablation Catheter and Ibi 1500T9-CP V1.6 Cardiac Ablation Generator · 01/25/2012 · 91 supplements
- P100029 ST Jude Medical Trifecta Valve · 04/20/2011 · 46 supplements
- P060040 Thoratec Heartmate II Left Ventricular Assist System · 04/21/2008 · 124 supplements
- P040040 Amplatzer Muscular VSD Occluder · 09/07/2007 · 47 supplements
- P040021 SJM Biocor Valve / SJM Biocor Supra Valve · 08/05/2005 · 59 supplements
- P030054 ST Jude Medical Epic HF System · 06/30/2004 · 427 supplements
- P030035 Anthem and Frontier II Crt-P'S · 05/13/2004 · 202 supplements
- P020024 Amplatzer Duct Occluder and 180 Degree Delivery System · 05/14/2003 · 65 supplements
- P000039 The Amplatzer(R) Septal Occluder (Aso) and the Amplatzer Exchange System · 12/05/2001 · 76 supplements
- P010032 Genesis and Eon Family Neurostimulation (Ipg) Systems · 11/21/2001 · 242 supplements
- P970013 Microny Pacemakers · 12/21/2000 · 94 supplements
- P960030 Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads · 01/29/1998 · 81 supplements
- P960013 Tendril DX Model 1388T & 1388K Endocardial Pacing Leads · 06/20/1997 · 129 supplements
- P950022 Tvl(Tm) Lead System · 05/10/1996 · 145 supplements
- P910023 Cadence(R) Tiered Therapy Defibrillation System · 04/30/1993 · 461 supplements
- P880086 Accent, Identity, Verity, Victory and Zephyr Pacemakers · 08/21/1989 · 328 supplements
- P810002 Bileaflet-Center Opening Cardiac Valve · 12/17/1982 · 119 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2405-2026 Class II | Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 softwareSoftware malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not… | 05/12/2026Open, Classified |
| Z-0459-2026 Class II | Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators… | 10/06/2025Open, Classified |
| Z-0458-2026 Class II | Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators… | 10/06/2025Open, Classified |
| Z-1557-2025 Class II | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code:…Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures… | 02/15/2025Open, Classified |
| Z-0753-2025 Class II | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a…Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific… | 11/21/2024Open, Classified |
| Z-0495-2025 Class II | Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, SterileA manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | 10/17/2024Open, Classified |
| Z-0494-2025 Class II | Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27…A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | 10/17/2024Open, Classified |
| Z-0493-2025 Class II | Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29…A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | 10/17/2024Open, Classified |
| Z-0492-2025 Class II | Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, SterileA manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | 10/17/2024Open, Classified |
| Z-0491-2025 Class II | Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm…A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | 10/17/2024Open, Classified |
| Z-0552-2025 Class III | Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with…Due to heart transmitter not being able to upgrade to the current software version in the field after… | 10/01/2024Open, Classified |
| Z-0551-2025 Class III | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to…Due to heart transmitter not being able to upgrade to the current software version in the field after… | 10/01/2024Open, Classified |
| Z-2432-2024 Class II | Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may… | 05/22/2024Open, Classified |
| Z-2431-2024 Class II | Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may… | 05/22/2024Open, Classified |
| Z-2430-2024 Class II | Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may… | 05/22/2024Open, Classified |
| Z-2429-2024 Class II | Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may… | 05/22/2024Open, Classified |
| Z-2369-2024 Class II | Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2368-2024 Class II | Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2367-2024 Class II | Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2366-2024 Class II | Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2365-2024 Class II | Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2364-2024 Class II | Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2363-2024 Class II | Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2362-2024 Class II | Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2361-2024 Class II | Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2360-2024 Class II | Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2359-2024 Class II | Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2358-2024 Class II | Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyThe duration between the implantable pulse generator reaching the elective replacement indicator threshold… | 05/16/2024Open, Classified |
| Z-2265-2024 Class II | Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLYDeep brain stimulation system will first turn off after approximately 50 days after the system is activated… | 05/16/2024Open, Classified |
| Z-1695-2024 Class II | Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEOTheir is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. | 02/05/2024Open, Classified |
| Z-2615-2023 Class II | Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q…Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia… | 08/16/2023Open, Classified |
| Z-2614-2023 Class II | Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR…Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia… | 08/16/2023Open, Classified |
| Z-2511-2023 Class I | Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable…Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on… | 07/18/2023Open, Classified |
| Z-2510-2023 Class I | Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable…Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on… | 07/18/2023Open, Classified |
| Z-2509-2023 Class I | Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable…Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on… | 07/18/2023Open, Classified |
| Z-2508-2023 Class I | Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The…Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on… | 07/18/2023Open, Classified |
| Z-2507-2023 Class I | Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The…Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on… | 07/18/2023Open, Classified |
| Z-2506-2023 Class I | Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7…Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on… | 07/18/2023Open, Classified |
| Z-2505-2023 Class I | Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5…Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on… | 07/18/2023Open, Classified |
| Z-0789-2020 Class II | Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 -…Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the… | 12/09/2019Terminated |
| Z-0783-2020 Class II | Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the… | 12/09/2019Terminated |
| Z-0720-2020 Class II | CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S -…A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip… | 11/11/2019Terminated |
| Z-0664-2020 Class II | Radiofrequency Grounding Pad, REF RF-DGP-LAffected lots were manufactured with the protective release liner in an incorrect orientation. When… | 10/14/2019Terminated |