Z-0498-05

Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System ( A= 22mm, B=112mm...

Name: Z-0498-05 Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System ( A= 22mm, B=112mm...
Creator: Cook, Inc.
Published: 2004-12-20
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2004-12-20 / Terminated

FDA source

Cook, Inc. began a recall of Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System ( A= 22mm, B=112mm, C=82mm, D=11mm, E= 18.0f, F=.035'', G =40cm)... on 2004-12-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0498-05
Status: Terminated
Initiated: 2004-12-20
Posted: 2005-02-03
Terminated: 2005-12-02
Recalling firm: Cook Incorporated
Product: Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System ( A= 22mm, B=112mm, C=82mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-82.
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Distribution: Nationwide and Canada.
Product codes and lots: All units distributed on or before 12/17/04.

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)