Class 2 Device Recall Zilver 518 Vascular Self Expanding Stent

• Date Initiated by Firm: January 05, 2012
• Date Posted: September 01, 2012
• Recall Status: Terminated on February 04, 2013
• Recall Number: Z-2309-2012
• Recall Event ID: 61451
• PMA Number: P050017
• Product Classification: Stent, iliac - Product Code NIO
• 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.
• Code Information: Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
• FEI Number: 3001845648
• Recalling Firm/ Manufacturer: Cook Ireland Ltd.; O'holloran Road,; National Technological Park; Limerick, Peroc Ireland
• For Additional Information Contact: Rita Harden; 800-346-2686 Ext. 2222
• Manufacturer Reason for Recall: 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 Determined Cause: Packaging process control
• Action: The firm, Cook Medical, sent a letter dated February 13, 2012 to foreign consignee. The letter described the product, problem and actions taken. The firm stated that re-training of the relevant personnel has been carried out; they will continue to monitor to identify potential emerging trends and further corrective and preventive action will be considered in an effort to avoid the recurrence of similar events. If you have any question contact in US: Customer Relations Manager at 800.346.2686.ext 2222 or email: rita.harden@cookmedical.com; OUS: Customer Quality Supervisor at +353 61 239343.
• Quantity in Commerce: 15 units of ZIV5-18-125-8-80 LOT# CF694429
• Distribution: Worldwide distribution: USA (nationwide) and country of: Japan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NIO