Recall Z-3130-2011 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Cook, Inc.
Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-82-ZT, REF G48407, 18 Fr ID/ 7.1 mm OD, Sterile
| Date | Sep 6, 2011 (initiated Apr 15, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 4 units |
| Distribution | US, Canada, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.