Home › Bard Peripheral Vascular, Inc. › E-Luminexx® Vascular & Biliary Stent
E-Luminexx® Vascular & Biliary Stent
Bard Peripheral Vascular, Inc. · Model ZBM07060 · UDI-DI 04049519009322
0
510(k) clearances
7,195
Adverse events (210 deaths)
7
Recalls
37
Facilities
Description
Bard® E-LUMINEXX™ Vascular and Biliary Stent 7 mm x 60 mm (80 cm delivery catheter)
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 Conditional" not "MRI |
| 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 during deployment. Fai |
| 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 ZIV5-18-125-8-80 from Lot# |
| 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 validated with the c |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.