Introducer, Catheter
FDA product code DYB · Class II (moderate risk) · 21 CFR 870.1340 · Cardiovascular
706510(k) clearances
0PMA approvals
337recalls
Manufacturers
- Terumo Medical Corp. 27
- St Jude Medical 26
- Cordis Corp. 22
- Cook, Inc. 20
- Merit Medical Systems, Inc. 19
- Daig Corp. 18
- Thomas Medical Products, Inc. 17
- C.R. Bard, Inc. 16
- Boston Scientific Corporation 16
- Medamicus, Inc. 14
- Edwards Lifesciences, LLC 14
- Access Scientific LLC 13
- Oscor, Inc. 13
- Arstasis, Inc. 12
- Acumen Medical, Inc. 9
- Arrow Intl., Inc. 9
- Argon Medical Devices, Inc 9
- B. Braun Medical, Inc. 9
- Baylis Medical Co., Inc. 8
- Medtronic Vascular 7
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | Medline Industries, LP | 07/29/2026SE |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…DYB · Traditional | Hartman Medical Group, LLC | 07/06/2026SE |
| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
| K260942 | AuST Steerable SheathDYB · Special | CenterPoint Systems, LLC | 04/07/2026SE |
| K260459 | VANES Delivery System (VDS)DYB · Traditional | Zoll Respicardia, Inc. | 04/06/2026SE |
| K260626 | Multiflex Steerable Sheath 17.5FDYB · Special | Vizaramed, Inc. | 03/26/2026SE |
| K260163 | AuST CSP IntroducerDYB · Special | CenterPoint Systems, LLC | 02/19/2026SE |
| K254236 | Peel-Away Introducer SheathDYB · Traditional | VascuTech Medical, LLC | 02/09/2026SE |
| K253652 | Genie MAX Large Bore Introducer SheathDYB · Traditional | Cultiv8 1, LLC | 01/22/2026SE |
| K252508 | Intri26 Introducer SheathDYB · Traditional | Inari Medical, Inc. | 12/17/2025SE |
| K253741 | VStick Vascular Access SetDYB · Special | Argon Medical Devices, Inc. | 12/15/2025SE |
| K252309 | PerQseal IntroducersDYB · Traditional | Vivasure Medical Limited | 10/23/2025SE |
| K251838 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 10/21/2025SE |
| K252766 | 14Fr Low Profile Introducer KitDYB · Special | Abiomed, Inc. | 10/08/2025SE |
| K252441 | Primero Safe Access SystemDYB · Traditional | South53, LLC | 09/29/2025SE |
| K252227 | Pounce(TM) SheathDYB · Special | Surmodics,Inc. | 09/24/2025SE |
| K252027 | Vertex(TM) CatheterDYB · Traditional | Jupiter Endovascular | 09/12/2025SE |
| K252364 | Edwards eSheath Optima introducer setDYB · Special | Edwards Lifesciences | 08/29/2025SE |
| K251051 | AuST Steerable SheathDYB · Special | CenterPoint Systems, LLC | 04/30/2025SE |
| K250909 | Prelude Wave Hydrophilic Sheath IntroducerDYB · Special | Merit Medical Systems, Inc. | 04/25/2025SE |
| K243954 | PeriCross Epicardial Access KitDYB · Traditional | Circa Scientific, Inc. | 04/24/2025SE |
| K244046 | Edwards eSheath Optima introducer setDYB · Traditional | Edwards Lifesciences | 03/27/2025SE |
| K250468 | iSLEEVE Introducer SetDYB · Special | Boston Scientific | 03/20/2025SE |
| K243928 | ViaOne Epicardial Access SystemDYB · Traditional | Cardiovia , Ltd. | 03/20/2025SE |
| K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm…DYB · Special | Contract Medical International, GmbH | 03/16/2025SE |
| K243493 | Agilis NxT Steerable Introducer Dual-ReachDYB · Special | Abbott Medical | 12/13/2024SE |
| K242520 | Element Vascular Access SystemDYB · Traditional | Penumbra, Inc. | 11/20/2024SE |
| K242756 | Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090…DYB · Traditional | Pulnovo Medical (Wuxi) Co., Ltd. | 11/08/2024SE |
| K243061 | SonoStik Guide Wire IntroducerDYB · Special | Sonostik, LLC | 11/04/2024SE |
| K242106 | AuST Steerable SheathDYB · Special | CenterPoint Systems, LLC | 10/04/2024SE |
| K241230 | Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008DYB · Traditional | Togo Medikit Co., Ltd. | 09/17/2024SE |
| K240600 | SafeCross Vascular Introducer System (4001)DYB · Special | East End Medical I, LLC | 09/06/2024SE |
| K242169 | Morph DNA Steerable Introducer SheathDYB · Special | Biocardia | 08/23/2024SE |
| K242248 | Introducer Sheath KitsDYB · Special | Beijing Demax Medical Technology Co.,Ltd | 08/22/2024SE |
| K240957 | Catapult Guide SheathDYB · Special | Contract Medical International, GmbH | 08/14/2024SE |
| K241708 | Abiomed 14Fr Low Profile Introducer KitDYB · Traditional | Abiomed, Inc. | 08/06/2024SE |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C)DYB · Traditional | Argon Medical Devices, Inc. | 08/01/2024SE |
| K241370 | Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)DYB · Special | Abbott Medical | 06/13/2024SE |
| K240829 | AuST Steerable SheathDYB · Traditional | CenterPoint Systems, LLC | 05/01/2024SE |
| K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access SetsDYB · Special | Cook Medical | 03/25/2024SE |
| K233708 | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)DYB · Traditional | Synaptic Medical Corporation | 02/16/2024SE |
| K233959 | EPi-Ease Epicardial Access Device (EAS)DYB · Traditional | AtriCure, Inc. | 02/13/2024SE |
| K240004 | CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath…DYB · Special | Circa Scientific, Inc. | 01/31/2024SE |
| K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathDYB · Traditional | Baylis Medical Company, Inc. | 12/20/2023SE |
| K233691 | FlexCath Cross Transseptal SolutionDYB · Traditional | Acutus Medical, Inc. | 12/17/2023SE |
| K233646 | Intri24 Introducer Sheath (52-101)DYB · Special | Inari Medical, Inc. | 12/12/2023SE |
| K233432 | 10F Sheath and Dilator SetDYB · Traditional | Argon Medical Devices, Inc. | 12/08/2023SE |
| K233503 | 14F iSLEEVE Introducer SetDYB · Special | Boston Scientific Corporation | 11/30/2023SE |
| K232260 | Thinline Sheath IntroducerDYB · Traditional | Inneuroco, Inc. | 09/27/2023SE |
| K231108 | Talon Transseptal SheathDYB · Traditional | Inari Medical, Inc. | 09/27/2023SE |
| K231828 | Pounce SheathDYB · Traditional | Surmodics,Inc. | 09/07/2023SE |
| K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)DYB · Special | Biosense Webster, Inc. | 07/10/2023SE |
| K230631 | Kodiak Dual Port Coaxial Introducer KitDYB · Traditional | Argon Medical Devices | 05/22/2023SE |
| K230704 | RAIN Sheath Tibial Pedal IntroducerDYB · Traditional | Cordis US Corp | 04/24/2023SE |
| K230283 | Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122…DYB · Special | Abbott Medical | 03/01/2023SE |
| K222184 | Introducer Sheath KitsDYB · Traditional | Beijing Demax Medical Technology Co.,Ltd | 02/21/2023SE |
| K230051 | 14F iSLEEVE Introducer SetDYB · Special | Boston Scientific Corporation | 02/03/2023SE |
| K223872 | Low Profile Companion SheathDYB · Special | Merit Medical Systems, Inc. | 01/19/2023SE |
| K221655 | Multiflex Steerable SheathDYB · Traditional | Vizaramed, Inc. | 11/14/2022SE |
| K222113 | Abiomed 14Fr Low Profile Introducer SetDYB · Traditional | Abiomed, Inc. | 10/13/2022SE |
| K221914 | Catapult Guide SheathDYB · Special | Contract Medical International, GmbH | 07/29/2022SE |
| K213582 | Epicardial Access SystemDYB · Special | Baylis Medical Company, Inc. | 06/30/2022SE |
| K221440 | Liverty TIPS Access SetDYB · Traditional | Bard Peripheral Vascular, Inc. | 05/31/2022SE |
| K220414 | VersaCross Connect Transseptal DilatorDYB · Special | Baylis Medical Company, Inc. | 05/09/2022SE |
| K220604 | EXTesia Introducer Sheath SetDYB · Traditional | Curatia Medical Co. | 04/27/2022SE |
| K212392 | Intri24 SheathDYB · Traditional | Inari Medical, Inc. | 04/01/2022SE |
| K213492 | Dib UltraNav Transseptal Catheter SystemDYB · Traditional | Dib Ultranav Medical, LLC | 03/24/2022SE |
| K212626 | PathBuilder Transseptal Guiding IntroducerDYB · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 03/23/2022SE |
| K220047 | AcQCross Qx Integrated Transseptal Dilator/NeedleDYB · Traditional | Acutus Medical, Inc. | 02/08/2022SE |
| K211530 | PathBuilder Steerable IntroducerDYB · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 02/08/2022SE |
| K212152 | Prelude IDeal 9F Hydrophilic Sheath IntroducerDYB · Traditional | Merit Medical Systems | 01/07/2022SE |
| K213638 | Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein…DYB · Special | Argon Medical Devices | 12/10/2021SE |
| K213002 | SCORPION Portal Vein Access SetDYB · Special | Argon Medical Devices | 10/14/2021SE |
| K211405 | Prelude Guide SheathDYB · Traditional | Merit Medical Systems, Inc. | 10/04/2021SE |
| K212708 | Halo One Thin-Walled Guiding SheathDYB · Special | C.R. Bard, Inc. | 09/23/2021SE |
| K211989 | Aveir IntroducerDYB · Special | Abbott Medical | 07/27/2021SE |
| K210185 | CardioCurve Steerable SheathDYB · Traditional | Talon Surgical | 07/23/2021SE |
| K203459 | SafeCross Transseptal Puncture and Introducer (TSP/I) SystemDYB · Traditional | East End Medical I, LLC | 07/06/2021SE |
| K210627 | Breezeway IIDYB · Special | Oscor, Inc. | 06/03/2021SE |
| K210685 | AcQCross Qx Integrated Transseptal Dilator/NeedleDYB · Traditional | Acutus Medical, Inc. | 04/06/2021SE |
| K202167 | Brite Tip Radianz Guiding SheathDYB · Traditional | Cordis Corporation | 02/26/2021SE |
| K203670 | Extra Large Check-Flo IntroducerDYB · Traditional | Cook Incorporated | 02/16/2021SE |
| K202141 | Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access SetDYB · Traditional | Argon Medical Devices, Inc. | 01/15/2021SE |
| K201489 | Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein…DYB · Traditional | Argon Medical Devices, Inc. | 12/22/2020SE |
| K202226 | Lim Precision Steerable TS, Steerable Sheath, DilatorDYB · Traditional | Keystone Heart, Ltd. | 12/15/2020SE |
| K202330 | Impella XR Sheath SetDYB · Traditional | Abiomed, Inc. | 12/07/2020SE |
| K203179 | Fortress Introducer Sheath SystemDYB · Special | Contract Medical International, GmbH | 11/20/2020SE |
| K202584 | iSleeve Introducer SetDYB · Special | Boston Scientific Corporation | 10/06/2020SE |
| K201116 | Abiomed 23 Fr SheathDYB · Traditional | Abiomed, Inc. | 06/15/2020SE |
| K200258 | Edwards eSheath Introducer SetDYB · Traditional | Edwards Lifesciences | 03/09/2020SE |
| K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QXDYB · Traditional | Acutus Medical, Inc. | 01/17/2020SE |
| K193125 | R2P Destination Slender Guiding SheathDYB · Traditional | Terumo Medical Corporation | 01/06/2020SE |
| K192313 | Halo One Thin-Walled Guiding SheathDYB · Traditional | C.R. Bard, Inc. | 12/19/2019SE |
| K193160 | Glidesheath Slender Tibial Pedal KitDYB · Special | Terumo Medical Coporation | 12/03/2019SE |
| K192769 | Impella CP IntroducerDYB · Traditional | Abiomed, Inc. | 11/18/2019SE |
| K192106 | AcQRef Introducer SheathDYB · Special | Acutus Medical, Inc. | 09/03/2019SE |
| K191871 | 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetDYB · Special | Boston Scientific Corporation | 08/07/2019SE |
| K191546 | Epicardial Access SystemDYB · Traditional | Baylis Medical Company, Inc. | 08/02/2019SE |
| K191190 | Steerable IntroducerDYB · Traditional | Freudenberg Medical, LLC | 08/01/2019SE |
| K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C®…DYB · Traditional | Access Scientific, LLC | 07/25/2019SE |
| K190628 | FlexSeal Introducer Sheath with Hydrophilic CoatingDYB · Traditional | Freudenberg Medical Mis, Inc. | 05/30/2019SE |
| K183655 | VersaCross Transseptal SheathDYB · Traditional | Baylis Medical Company, Inc. | 05/20/2019SE |
| K190974 | D'Vill IntroducerDYB · Special | NuMED, Inc. | 05/14/2019SE |
| K190941 | BioCardia 8.5 F Avance Steerable lntroducerDYB · Traditional | Biocardia, Inc. | 05/06/2019SE |
| K190644 | Guide SheathDYB · Traditional | Surmodics,Inc. | 04/18/2019SE |
| K190688 | VersaCross Steerable Sheath, VersaCross Transseptal DilatorDYB · Special | Baylis Medical Company, Inc. | 04/17/2019SE |
| K190369 | M-Y SheathDYB · Traditional | Ram Medical Innovations, Inc. | 04/17/2019SE |
| K181817 | transGlideXT Expandable IntroducerDYB · Traditional | Transaortic Medical, Inc. | 03/26/2019SE |
| K190184 | iSLEEVE Introducer SetDYB · Special | Boston Scientific | 03/07/2019SE |
| K190098 | Endophys Pressure Sensing SheathDYB · Special | Endophys Holdings, LLC | 03/07/2019SE |
| K181463 | DuraSheath Introducer Sheath SystemDYB · Traditional | Contract Medical International, GmbH | 12/13/2018SE |
| K181031 | TSI Transseptal IntroducerDYB · Traditional | Pressure Products Medical Device Manufacturing… | 10/26/2018SE |
| K180620 | Endophys Pressure Sensing Sheath KitDYB · Special | Endophys Holdings, LLC | 10/12/2018SE |
| K181088 | TSP Crosser Transseptal Access SystemDYB · Traditional | Transseptal Solutions , Ltd. | 09/28/2018SE |
| K182243 | The CVC WAND Safety Introducer with Valved Peelable SheathDYB · Special | Access Scientific, LLC | 09/18/2018SE |
| K181592 | RAIN Sheath TransradialDYB · Traditional | Cordis Corporation | 08/15/2018SE |
| K181237 | Glidesheath Slender Tibial Pedal KitDYB · Traditional | Terumo Medical Corporation | 08/03/2018SE |
| K181855 | RadialSeal Introducer KitDYB · Traditional | Great Batch Medical | 07/26/2018SE |
| K180785 | iSLEEVE Introducer SetDYB · Traditional | Boston Scientific Corporation | 06/22/2018SE |
| K171609 | Check-Flo Performer Introducer Micropuncture Radial Artery Access SetDYB · Traditional | Cook Incorporated | 06/04/2018SE |
| K180913 | VSI Micro-Introducer KitDYB · Traditional | Vascular Solutions, Inc. | 05/09/2018SE |
| K173831 | Glidesheath SlenderDYB · Traditional | Terumo Medical Corporation | 05/08/2018SE |
| K172980 | Micropuncture Pedal Access SetDYB · Traditional | Cook Incorporated | 05/03/2018SE |
| K180081 | RAILWAY Sheathless Access SystemDYB · Traditional | Cordis Corporation | 04/18/2018SE |
| K171988 | Performer Guiding SheathDYB · Traditional | Cook Incorporated | 03/30/2018SE |
| K171820 | Transjugular Liver Access SetsDYB · Traditional | Cook Incorporated | 03/09/2018SE |
| K172331 | Type I, Type II, Type III, Type IVDYB · Traditional | Lepu Medical Technology (Beijing) Co., Ltd. | 03/02/2018SESK |
| K173750 | Prelude IDeal Hydrophilic Sheath IntroducerDYB · Special | Merit Medical Systems, Inc. | 02/15/2018SE |
| K171557 | AcQRef Introducer SheathDYB · Traditional | Acutus Medical, Inc. | 02/06/2018SE |
| K173287 | Elite HV RadialDYB · Traditional | Galt Medical Corp. | 12/21/2017SESK |
| K173685 | Peel-Away Introducer SetDYB · Special | Cook Incorporated | 12/20/2017SE |
| K171866 | Sentrant Introducer Sheath with Hydrophilic CoatingDYB · Special | Medtronic Vascular, Inc. | 12/20/2017SE |
| K171275 | Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…DYB · Special | Cook Incorporated | 12/20/2017SESK |
| K173399 | Endophys Pressure Sensing Sheath Kit- 8FDYB · Traditional | Endophys Holdings, LLC | 11/30/2017SE |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…DYB · Traditional | Terumo Medical Corporation | 11/21/2017SE |
| K173068 | Performer IntroducerDYB · Traditional | Cook Incorporated | 11/17/2017SE |
| K171206 | D'Vill IntroducerDYB · Traditional | NuMED, Inc. | 10/20/2017SE |
| K172099 | Shoocin Introducer KitDYB · Traditional | Lepu Medical Technology (Beijing) Co., Ltd. | 10/05/2017SE |
| K171491 | R2P Destination Slender Guiding SheathDYB · Traditional | Terumo Medical Corporation | 10/05/2017SE |
| K170020 | Peel-Away Introducer SetDYB · Traditional | Cook Incorporated | 09/28/2017SE |
| K172117 | Prelude Pursuit Splittable Sheath IntroducerDYB · Traditional | Merit Medical Systems, Inc. | 09/11/2017SESK |
| K171853 | Liver Access and Biopsy SetsDYB · Traditional | Cook Incorporated | 08/24/2017SE |
| K171999 | Performer IntroducerDYB · Special | Cook Incorporated | 07/31/2017SE |
| K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding SheathDYB · Traditional | Biosense Webster, Inc. | 07/25/2017SE |
| K170775 | Mini Stick ENVI Non-Vascular Introducer KitDYB · Traditional | AngioDynamics, Inc. | 07/19/2017SE |
| K170695 | VenaCure EVLT NeverTouch Direct Introducer SheathDYB · Traditional | AngioDynamics, Inc. | 05/30/2017SE |
| K171081 | Guider Catheter IntroducerDYB · Traditional | Rhythm Xience, Inc. (Rxi) | 05/09/2017SE |
| K170831 | EpiAccess SystemDYB · Special | Epiep, Inc. | 05/09/2017SE |
| K170668 | HeartSpan Steerable Sheath IntroducerDYB · Special | Merit Medical Systems, Inc. | 04/05/2017SE |
| K160721 | Vado Steerable SheathDYB · Traditional | Kalila Medical, Inc. | 03/07/2017SE |
| K170373 | Flextra Steerable IntroducerDYB · Traditional | Rhythm Xience, Inc. (Rxi) | 02/27/2017SE |
| K163268 | FlexCath Select Steerable Shealth and DilatorDYB · Traditional | Medtronic Cryocath, LP | 02/02/2017SE |
| K162427 | Vado Bi-Directional Steerable SheathDYB · Traditional | Kalila Medical, Inc. | 01/27/2017SE |
| K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelDYB · Traditional | Access Scientific, LLC | 11/17/2016SE |
| K162097 | InTRAkitDYB · Traditional | Medtronic Vascular | 11/17/2016SE |
| K162769 | Pinpoint GT Introducer NeedleDYB · Special | C.R. Bard, Inc. | 11/04/2016SE |
| K153771 | TXM Guiding SheathDYB · Traditional | Texasmedical Technologies, Inc. | 09/13/2016SE |
| K162184 | Edwards eSheath Introducer SetDYB · Special | Edward Lifesciences | 09/02/2016SE |
| K153494 | HQS Introducer (Model 2064-HQS)DYB · Traditional | Alseal | 08/25/2016SE |
| K152913 | GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleDYB · Traditional | Creganna Medical Aslo Business AS Cregganna… | 07/21/2016SE |
| K161659 | FlexSeal Introducer Sheath with Hydrophilic CoatingDYB · Traditional | Libramedical, Inc. | 07/15/2016SE |
| K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerDYB · Traditional | Galt Medical Corp. | 07/05/2016SE |
| K161183 | Halo One Thin-Walled Guiding SheathDYB · Traditional | C.R. Bard, Inc. | 06/03/2016SE |
| K161102 | Nanostim Introducer KitDYB · Special | St. Jude Medical, Inc. | 05/19/2016SE |
| K160254 | GORE DrySeal Flex Introducer SheathDYB · Traditional | W. L. Gore & Associates, Inc. | 05/12/2016SE |
| K160716 | The Nanostim Introducer KitDYB · Special | St. Jude Medical, Inc. | 04/14/2016SE |
| K152194 | transGlide Expandable IntroducerDYB · Traditional | Transaortic Medical, Inc. | 04/07/2016SE |
| K153430 | Flexor Tuohy-Borst Side-Arm Introducers Shuttle SelectDYB · Special | Cook Incorporated | 03/07/2016SE |
| K160272 | Endophys Pressure Sensing Sheath KitDYB · Special | Endophys, Inc. | 03/04/2016SE |
| K153246 | PTFE Super Sheath Introducer 2.1DYB · Special | Medcomp (Medical Components, Inc.) | 02/12/2016SE |
| K153197 | Fortress Introducer Sheath SYstemDYB · Special | Contract Medical International, GmbH | 01/11/2016SE |
| K152498 | SoloPath Re-Collapsible Access SystemDYB · Traditional | Onset Medical Corporation | 01/05/2016SE |
| K151936 | Steerable Intracardiac Catheter Introducer Kit and Transseptal NeedleDYB · Traditional | Synaptic Medical Limited | 12/04/2015SESK |
| K152173 | GlidesheathDYB · Traditional | Terumo Medical Corporation | 12/01/2015SE |
| K152225 | Edwards eSheath Introducer SetDYB · Traditional | Edwards Lifesciences | 11/24/2015SE |
| K152381 | Prelude SNAP Splittable Hydrophilic Sheath IntroducerDYB · Special | Merit Medical Systems, Inc. | 10/30/2015SE |
| K152177 | SonoStik IV Guide Wire IntroducerDYB · Traditional | Sonostik, LLC | 10/01/2015SE |
| K151951 | Destino ReachDYB · Special | Oscor, Inc. | 09/22/2015SE |
| K152116 | 5.5 F Worley Advanced LVI Lateral Vein IntroducerDYB · Special | Merit Medical Systems, Inc. | 08/27/2015SE |
| K152044 | Flexor Radial Hydrophilic Introducer Access SetDYB · Special | Cook Incorporated | 08/14/2015SE |
| K152054 | Confida Adaptive SheathDYB · Traditional | Medtronic, Inc. | 08/07/2015SE |
| K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…DYB · Traditional | Cook Incorporated | 07/28/2015SE |
| K142819 | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer SetDYB · Traditional | Cook Incorporated | 07/24/2015SE |
| K142357 | DuraSheath Introducer Sheath SystemDYB · Traditional | Contract Medical International, GmbH | 06/25/2015SE |
| K150257 | PreludeEASE Hydrophilic Sheath IntroducerDYB · Special | Merit Medical Systems, Inc. | 06/19/2015SESK |
| K150186 | Chariot Guiding SheathDYB · Traditional | Boston Scientific Corp | 06/05/2015SE |
| K142445 | Pinpoint GT Safety Introducer NeedleDYB · Traditional | C.R. Bard, Inc. | 04/13/2015SE |
| K143255 | Prelude SNAP Splittable Sheath IntroducerDYB · Traditional | Merit Medical Systems, Inc. | 04/09/2015SE |
| K141275 | Endophys Pressure Sensing Sheath KitDYB · Traditional | Endophys, Inc. | 01/07/2015SE |
| K141969 | Firststic N IntroducerDYB · Traditional | Argon Medical Devices, Inc. | 12/19/2014SE |
| K140793 | Nanostim Introducer KitDYB · Traditional | St. Jude Medical, Inc. | 12/17/2014SE |
| K140768 | Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type III Brilliant…DYB · Traditional | Lepu Medical Technology (Bejing) Co., Ltd. | 11/25/2014SE |
| K142183 | Glidesheath SlenderDYB · Special | Terumo Medical Corporation | 11/21/2014SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2930-2026 Class II | GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The…Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. | Terumo Medical Corporation | 06/15/2026Open, Classified |
| Z-2693-2026 Class I | ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2692-2026 Class I | ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2691-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2690-2026 Class I | ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2689-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2688-2026 Class I | ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2687-2026 Class I | ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2686-2026 Class I | ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2685-2026 Class I | ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2684-2026 Class I | ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2683-2026 Class I | ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2682-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2681-2026 Class I | ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2680-2026 Class I | Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer…Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the… | Oscor Inc. | 06/10/2026Open, Classified |
| Z-2679-2026 Class I | Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer…Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the… | Oscor Inc. | 06/10/2026Open, Classified |
| Z-2678-2026 Class I | Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer…Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the… | Oscor Inc. | 06/10/2026Open, Classified |
| Z-2602-2026 Class I | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…Potential for thrombus formation during prolonged use of the introducer. | Abiomed, Inc. | 05/22/2026Open, Classified |
| Z-2601-2026 Class I | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…Potential for thrombus formation during prolonged use of the introducer. | Abiomed, Inc. | 05/22/2026Open, Classified |
| Z-2600-2026 Class I | Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product…Potential for thrombus formation during prolonged use of the introducer. | Abiomed, Inc. | 05/22/2026Open, Classified |
| Z-2599-2026 Class I | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product…Potential for thrombus formation during prolonged use of the introducer. | Abiomed, Inc. | 05/22/2026Open, Classified |
| Z-2385-2026 Class I | Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2202-2026 Class II | Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P…Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal… | Becton, Dickinson and Company | 04/08/2026Open, Classified |
| Z-1577-2026 Class I | 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may… | Merit Medical Systems, Inc. | 02/13/2026Open, Classified |
| Z-0995-2026 Class II | Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The…Cook Medical identified that products supplied in the affected device lots may have been manufactured out of… | Cook Incorporated | 11/26/2025Open, Classified |
| Z-0994-2026 Class II | Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2)…Cook Medical identified that products supplied in the affected device lots may have been manufactured out of… | Cook Incorporated | 11/26/2025Open, Classified |
| Z-0993-2026 Class II | Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1)…Cook Medical identified that products supplied in the affected device lots may have been manufactured out of… | Cook Incorporated | 11/26/2025Open, Classified |
| Z-2532-2025 Class II | Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath…Units may have been packaged with an incorrect pouch label, which lists the reference number and unique… | Contract Medical International GmbH | 07/30/2025Open, Classified |
| Z-1787-2025 Class II | Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF…Cook Medical identified that devices from the affected device lots may contain the incorrectly sized… | Cook Incorporated | 04/17/2025Open, Classified |
| Z-1786-2025 Class II | Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF…Cook Medical identified that devices from the affected device lots may contain the incorrectly sized… | Cook Incorporated | 04/17/2025Open, Classified |
| Z-1733-2025 Class II | B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model…Due to a potential open seal in the sterile barrier packaging . | Galt Medical Corporation | 03/27/2025Open, Classified |
| Z-1434-2025 Class II | Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/DHydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect… | Merit Medical Systems, Inc. | 01/27/2025Open, Classified |
| Z-1048-2025 Class II | CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with…Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either… | MEDLINE INDUSTRIES, LP - Northfield | 12/23/2024Open, Classified |
| Z-0045-2025 Class II | Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number…Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the… | Cook Incorporated | 09/16/2024Open, Classified |
| Z-2577-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2575-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2574-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2572-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2571-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2218-2024 Class II | Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S…Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are… | Merit Medical Systems, Inc. | 05/22/2024Open, Classified |
| Z-2348-2024 Class II | St. Jude Medical Agilis NxT Steerable Introducer, REF 408309One lot of product has dilators that are too short and will not extend outside the introducer sheath. | St. Jude Medical | 04/30/2024Open, Classified |
| Z-1875-2024 Class II | Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX…Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. | Merit Medical Systems, Inc. | 03/14/2024Open, Classified |
| Z-1874-2024 Class II | Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX…Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. | Merit Medical Systems, Inc. | 03/14/2024Open, Classified |
| Z-1528-2024 Class II | Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode…Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | Cook Incorporated | 03/01/2024Open, Classified |
| Z-1390-2024 Class II | Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates…Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set… | Boston Scientific Corporation | 02/20/2024Open, Classified |
| Z-1290-2024 Class II | CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM…Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main… | Biosense Webster, Inc. | 02/16/2024Open, Classified |
| Z-0655-2024 Class II | Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | Abiomed, Inc. | 11/07/2023Open, Classified |
| Z-0654-2024 Class II | Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | Abiomed, Inc. | 11/07/2023Open, Classified |
| Z-0653-2024 Class II | Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | Abiomed, Inc. | 11/07/2023Open, Classified |
| Z-0652-2024 Class II | Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | Abiomed, Inc. | 11/07/2023Open, Classified |