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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 AAAsee related information
Date Initiated by FirmApril 15, 2011
Date PostedSeptember 06, 2011
Recall Status1 Terminated 3 on September 13, 2011
Recall NumberZ-3136-2011
Recall Event ID 58613
PMA NumberP020018 
Product Classification endovascular graft system - Product Code MIH
ProductCook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-82-ZT, REF G48427, 20 Fr ID/ 7.7 mm OD, Sterile.
Code Information 2687768 
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 2
Process control
ActionThe 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 Commerce1 unit
DistributionUS, Canada, Japan
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MIH
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