Gore TAG Thoracic Branch Endoprosthesis Side Branch Component
Gore is recalling 30+ models of the TAG Thoracic Branch Endoprosthesis Side Branch Component due to a risk of catheter separation.
Healthcare providers should immediately stop using the affected endoprosthesis components and return them to the manufacturer. Contact W. L. Gore & Associates for further instructions regarding patient monitoring and product replacement.
Why it was recalled
W. L. Gore & Associates is recalling 30+ models of the GORE TAG Thoracic Branch Endoprosthesis Side Branch Component due to a risk of catheter separation. This defect may lead to procedural complications during the endovascular repair of aortic arch and descending thoracic aorta lesions. The full list of affected catalog numbers is available on the FDA recall page.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| 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 Taiwa | 00733132654369, 31602664, 00733132662630, 31421864, 31421865, 31421870, 31432339, 31432340, 31440637, 31440638, 31440639, 31440640, 31440641, 31440642, 31462061, 31462062, 31462063, 31462064, 00733132650866, 31530086 | Z-2672-2026 |
| 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¿ Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel The GORE¿ TAG¿ Thoracic Branch Endoprosthesis is a modular device consisting of the Aortic Component (AC), the Side Branch (SB) Component, and an optional Aortic Extender (AE), and their respective delivery systems. These components may be used together as a stand-alone device or in conjunction with the GORE¿ TAG¿ Conformable Thoracic Endoprosthesis to accommodate the intended treatment site. | – | – |
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-07-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification