Home › Device types › NIP
Stent, Superficial Femoral Artery
FDA product code NIP · Class 3 · Unknown
0
Registered devices
10,730
Adverse events
86
Recalls
0
510(k) clearances
Devices with this code
EverFlex — Covidien LPGORE VIABAHN Endoprosthesis with Heparin — W. L. Gore & Associates, Inc.TIGRIS Vascular Stent — W. L. Gore & Associates, Inc.Innova™ Vascular — BOSTON SCIENTIFIC CORPORATIONPulsar-18 T3 — Biotronik AGLifeStent® Vascular & Biliary Stent — Bard Peripheral Vascular, Inc.Pulsar-18 — Biotronik AGGORE VIABAHN Endoprosthesis with Heparin — W. L. Gore & Associates, Inc.S.M.A.R.T. RADIANZ — Cordis US Corp.LifeStent® Solo Vascular Stent — Bard Peripheral Vascular, Inc.Pulsar-18 T3 — Biotronik AGLifeStent® XL Vascular & Biliary Stent System — Bard Peripheral Vascular, Inc.EverFlex™ — Covidien LPPulsar-18 T3 — Biotronik AGLIFESTENT® — Bard Peripheral Vascular, Inc.GORE VIABAHN Endoprosthesis — W. L. Gore & Associates, Inc.LifeStent® Vascular & Biliary Stent System — Bard Peripheral Vascular, Inc.GORE VIABAHN Endoprosthesis — W. L. Gore & Associates, Inc.Zilver Flex — COOK IRELAND LTDPulsar-18 — Biotronik AGLifeStent® Solo Vascular Stent — Bard Peripheral Vascular, Inc.EverFlex — Covidien LPGORE VIABAHN Endoprosthesis — W. L. Gore & Associates, Inc.EverFlex™ — Covidien LP
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-20 | Medtronic Inc. | Seal defects could compromise the ability of the product packaging to maintain sterility. |
| 2022-07-14 | Medtronic Inc. | Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment. |
| 2019-11-14 | Cardinal Health Inc. | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Co |
| 2017-11-06 | Boston Scientific Corporation | Stent possibly unable to be fully released from the delivery system. |
| 2017-11-06 | Boston Scientific Corporation | Stent possibly unable to be fully released from the delivery system. |
| 2017-11-03 | Medtronic Inc. | Stent length on the label may not match the length of the stent itself. |
| 2016-08-04 | Terumo Medical Corp | During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal en |
| 2016-05-23 | Ev3, Inc. | Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding |
| 2013-09-30 | Bard Peripheral Vascular Inc | Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent |
| 2013-04-23 | Cordis Corporation | Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch. |
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