Reported Sep 12, 2012 · Terminated
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous…
Cook Ireland Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Ireland Ltd. · O'holloran Road, · Limerick, Peroc, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Part order numberZIV5-18-125-8-80
- Lot NumberCF694429
- Expiration Date09-2014
- Amount recalled
- 15 units of ZIV5-18-125-8-80 LOT# CF694429
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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