W L Gore & Associates, Inc.: System, Endovascular Graft, Aortic Aneurysm Treatment
Recall Summary W.L. Gore & Associates is recalling specific batches of GORE TAG Thoracic Branch Endoprosthesis Side Branch Components used to treat aortic aneurysms in the chest. The devices are being recalled because the catheter (delivery tube) can separate from the component during the procedure. The affected products were distributed worldwide, including throughout the United States, Canada, Europe, Asia, and Australia.
- Recalling firm
- W L Gore & Associates, Inc.
- Product
- 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, TSB081206J, TSB081506J, TSB081706J, TSB121506J, TSB121706J, TSB122006J China and Taiwan: TSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W The GORE TAG...
- Reason
- Due to catheter separation
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-19
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/95bb64d8-8eb0-486c-902d-ba6bd2c90f48