Z-1237-06

GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number...

Name: Z-1237-06 GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number...
Creator: W L Gore & Assoc, Inc.
Published: 2006-04-28
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2006-04-28 / Terminated / root cause: labeling and UDI

FDA source

W L Gore & Assoc, Inc. began a recall of GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm on 2006-04-28. The reason FDA records is "Two lots of uniquely different product were switched and mislabeled with the wrong length. 34mm x 10cm devices were mislabeled as 34mm x 15cm and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1237-06
Status: Terminated
Initiated: 2006-04-28
Posted: 2006-07-13
Terminated: 2006-12-13
Recalling firm: W. L. Gore & Associates, Inc.
Product: GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: Two lots of uniquely different product were switched and mislabeled with the wrong length. 34mm x 10cm devices were mislabeled as 34mm x 15cm and vice versa.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: All the letters were sent via Federal Express to each Gore Field Sales Associate (FSA) to be hand-delivered to the Physician and to the hospital Risk Manager. A cover note to the FSA directing them regarding the hand delivery of the letter. Also included is a memo to the FSA with a document that the FSA is directed to complete, sign/date and return to Gore documenting hand-delivery of each of these letters. These letters were to be hand delivered on 18 May, or 19 May, 2006.
Quantity in commerce: 10
Distribution: Nationwide to: AL, CT, KS, MA, & MN
Product codes and lots: Lot numbers: 04150272, 04150273, 04150274, 04150275, 04150276, 04150277, 04150278, 04150279, 04150280, & 04150281

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)