FDA Medical Device Recalls (openFDA)
W L Gore & Assoc, Inc.: GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
- Recall number
- Z-1237-06
- Recalling firm
- W L Gore & Assoc, Inc.
- Product
- GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
- Status
- Terminated
- Initiated
- 2006-04-28
- Posted
- 2006-07-13
- Terminated
- 2006-12-13
- Reason
- 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
- 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
- 10
- Distribution
- Nationwide to: AL, CT, KS, MA, & MN
- Lot, serial or model codes
- Lot numbers: 04150272, 04150273, 04150274, 04150275, 04150276, 04150277, 04150278, 04150279, 04150280, & 04150281
- 510(k) numbers
- not on file
- PMA numbers
- ["P040043"]
- Product code
- MIH
- Firm FEI
- 2017233
- Firm city
- Flagstaff
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28