—#99828

Product

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48473, 16Fr ID/ 6.0 mm OD, Sterile.

FDA product code: MIH — System, Endovascular Graft, Aortic Aneurysm Treatment
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P020018
Affected lot / code info: F2630176, F2630177

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Cook, Inc.
Address: 750 Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: US, Canada, Japan

Timeline

Recall initiated: 2011-04-15
Posted by FDA: 2011-09-06
Terminated: 2011-09-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99828. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.