Recall Z-2672-2026 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
W L Gore & Associates, Inc.
GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806E, TSB081006E, TSB081206E, TSB081506E, TSB081706E, TSB121506E, TSB121706E, TSB122006E Japan: TSB080806J, TSB081006J,
| Date | Jul 2, 2026 (initiated May 19, 2026) |
| Status | Open, Classified |
| Reason | Due to catheter separation |
| Root cause | Under Investigation by firm |
| Action | On 05/21/2026, the firm thru a third-party (Sedgwick) sent via certified mail an "URGENT Medical Device Safety Correction/Field Safety Notice" informing customer that Gore received 5 reports involving catheter separation of the GORE TAG Thoracic Branch Endoprosthesis (TBE) Side Branch (SB) Component during clinical use. In all cases, the failure occurred at the interface between the main catheter shaft and an over molded transition near where the trailing end of the device is positioned on the catheter. Customers are being reminded of pertinent Instructions for Use and Warnings and Considerat |
| Quantity | 467 devices |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states and territories of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI. The countries of United Arab Emirates, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.