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U.S. Department of Health and Human Services

Class 3 Device Recall Zenith Flex AAA

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  Class 3 Device Recall Zenith Flex AAA see related information
Date Initiated by Firm April 15, 2011
Date Posted September 06, 2011
Recall Status1 Terminated 3 on September 13, 2011
Recall Number Z-3152-2011
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-20-73-ZT, REF G48476, 16Fr ID/ 6.0 mm OD, Sterile.
Code Information F2630185 
Recalling Firm/
Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact
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 2
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 and Original Applicant = COOK, INC.