FDA Device recall Z-2309-2012
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplas…
- FDA Device
- Class II
- terminated
- Published 2012-09-12
On 2012-09-12 the FDA classified a Class II recall of Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplas… by Cook Ireland, citing 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#….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2309-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-01-05 |
| Published | 2012-09-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cook Ireland |
| Distribution | US |
Product
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
Reason
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# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35
Identifiers
| code_info | Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2309-2012%22
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