Home › Device types › NIO
Stent, Iliac
FDA product code NIO · Class 3 · Unknown
781
Registered devices
7,286
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
Visi-Pro™ — Covidien LPAbsolute Pro — ABBOTT VASCULAR INC.LifeStar® Vascular & Biliary Stent — Bard Peripheral Vascular, Inc.S.M.A.R.T. RADIANZ — Cordis US Corp.Absolute Pro — ABBOTT VASCULAR INC.COMPLETE® SE VASCULAR — MEDTRONIC, INC.Absolute Pro — ABBOTT VASCULAR INC.WALLSTENT™ RP Endoprosthesis — BOSTON SCIENTIFIC CORPORATIONWALLSTENT™ RP Endoprosthesis — BOSTON SCIENTIFIC CORPORATIONE-Luminexx® Vascular & Biliary Stent — Bard Peripheral Vascular, Inc.Visi-Pro™ — Covidien LPZilver 635 — COOK IRELAND LTDExpress® LD Iliac / Biliary — BOSTON SCIENTIFIC CORPORATIONASSURANT® COBALT — MEDTRONIC, INC.Epic™ Vascular — BOSTON SCIENTIFIC CORPORATIONAbsolute Pro — ABBOTT VASCULAR INC.Omnilink Elite — ABBOTT VASCULAR INC.Protégé™ GPS™ — EV3, INCLifeStar® Vascular & Biliary Stent — Bard Peripheral Vascular, Inc.Epic™ Vascular — BOSTON SCIENTIFIC CORPORATIONProtégé™ GPS™ — EV3, INCZilver 518 — COOK IRELAND LTDLifeStar® Vascular & Biliary Stent — Bard Peripheral Vascular, Inc.Visi-Pro™ — Covidien LP
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-04 | Cordis US Corp | product mix-up; Vascular stent labeled as one size but contains a different size. |
| 2025-03-04 | Cordis US Corp | product mix-up; Vascular stent labeled as one size but contains a different size. |
| 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 |
| 2015-12-22 | Cook Medical Incorporated | Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate du |
| 2012-01-31 | Cordis Corporation | Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Nitinol Iliac Stent System due to a potential sterility breach in the pouches. |
| 2012-01-05 | Cook Ireland Ltd. | Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-1 |
| 2008-03-10 | Cordis Corporation | Data transcription error. The 10 affected lots of Catalog Number C10040SL were manufactured with a prior version of the guidewire lumen material, which is not |
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