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Cook Ireland Ltd. recalls Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous
Recalled September 12, 2012 · FDA recall Z-2309-2012 · Cook Ireland
Hazard
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 · FDA Class II
Units
15 units of ZIV5-18-125-8-80 LOT# CF694429
Sold at
Worldwide distribution: USA (nationwide) and country of: Japan.
Description
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
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.
Manufacturer(s)
Cook Ireland Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →