Class 2 Device Recall

• Date Initiated by Firm: December 20, 2004
• Date Posted: February 03, 2005
• Recall Status: Terminated on December 02, 2005
• Recall Number: Z-0517-05
• Recall Event ID: 30721
• PMA Number: P020018
• Product Classification: System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
• Product: Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 24mm, B=155mm, C=125mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-125.
• Code Information: All units distributed on or before 12/17/04.
• Recalling Firm/ Manufacturer: Cook, Inc.; 750 Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Customer Relations; 800-457-4500
• Manufacturer Reason for Recall: The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.
• FDA Determined Cause: Other
• Action: Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm.
• Distribution: Nationwide and Canada.
• 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 = MIH