Z-1197-04

Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft...

Name: Z-1197-04 Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft...
Creator: Cook, Inc.
Published: 2004-06-10
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2004-06-10 / Terminated

FDA source

Cook, Inc. began a recall of Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 54mm -... on 2004-06-10. The reason FDA records is "Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1197-04
Status: Terminated
Initiated: 2004-06-10
Posted: 2004-07-27
Terminated: 2004-11-01
Recalling firm: Cook Incorporated
Product: Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 54mm - delivery system 16 FR; Catalog no. TFLE-18-54.
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
FDA root cause: Other
Action: The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
Quantity in commerce: 35
Distribution: Nationwide, Canada, Denmark and Japan.
Product codes and lots: Lots 1365980, 1365985, F1569284, F1569285, F1573011, F1573012, F1570180, F1570181, F1570182, F1570183, F1569256, F1569257, F1571582, F1576420, F1576421, F1576422, F1576423, F1575250, F1575251, F1575253, F1578444, F1578445, F1578447, F1578448, F1578449, F1575338, F1578373, F1575339, F1578375, F1575342, F1576417, F1576418, F1576419, 1368364 and 1368371.

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)