FDA-Device2012-09-12Class II
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.
Cook Ireland Ltd.
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
Sold states
Worldwide distribution: USA (nationwide) and country of: Japan.
Affected count
15 units of ZIV5-18-125-8-80 LOT# CF694429
Manufactured in
O'holloran Road,, National Technological Park, Limerick, Peroc, N/A, Ireland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2309-2012Don't want to check this manually?
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