Z-3140-2011

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449, 16Fr ID/ 6.0 mm OD...

Name: Z-3140-2011 Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449, 16Fr ID/ 6.0 mm OD...
Creator: Cook, Inc.
Published: 2011-04-15
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2011-04-15 / Terminated / root cause: manufacturing process

FDA source

Cook, Inc. began a recall of Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449, 16Fr ID/ 6.0 mm OD, Sterile on 2011-04-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3140-2011
Status: Terminated
Initiated: 2011-04-15
Posted: 2011-09-06
Terminated: 2011-09-13
Recalling firm: Cook Incorporated
Product: Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449, 16Fr ID/ 6.0 mm OD, Sterile.
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 4 units
Distribution: US, Canada, Japan
Product codes and lots: F2628879, F2628880, F2628882, F2628884

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)