—#36489

Product

Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-82.

FDA product code: MIH — System, Endovascular Graft, Aortic Aneurysm Treatment
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P020018
Affected lot / code info: All units distributed on or before 12/17/04.

Why it was recalled

The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.

Root cause (FDA determination)

Other

Action the firm took

Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Canada.

Timeline

Recall initiated: 2004-12-20
Posted by FDA: 2005-02-03
Terminated: 2005-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36489. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.