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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 61451
Product Type Devices
Status Ongoing
Recalling Firm Cook Ireland Ltd.
City Limerick, Peroc
Country IE
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-01-05
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: USA (nationwide) and country of: Japan.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014 Class II 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 ZIV6-35-80-10-30) rather than a 5 French size. 15 units of ZIV5-18-125-8-80 LOT# CF694429 Z-2309-2012