Class 3 Device Recall Zenith Flex AAA

• Date Initiated by Firm: April 15, 2011
• Date Posted: September 06, 2011
• Recall Status: Terminated on September 13, 2011
• Recall Number: Z-3139-2011
• Recall Event ID: 58613
• PMA Number: P020018
• Product Classification: endovascular graft system - Product Code MIH
• Product: Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-10-71-ZT, REF G48444, 14 Fr ID/ 5.3 mm OD, Sterile.
• Code Information: 2696926
• Recalling Firm/ Manufacturer: Cook, Inc.; 750 Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: 812-339-2235
• Manufacturer Reason for Recall: The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
• FDA Determined Cause: Process control
• Action: The firm sent URGENT PRODUCT RECALL notices dated 4/15/2011 to Risk Managers/Recall Administration (Chief of Vascular Surgery and or Interventional Radiology). The letters explained the problem with the devices and the action to be taken. Consignees were instructed to return the recalled devices to Cook Medical for credit or replacement. Customers with questions or concerns can contact the firm at 800-457-2235.
• Quantity in Commerce: 1 unit
• Distribution: US, Canada, 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 = MIH