GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component… — Class II medical device recall Z-2672-2026
Ongoing recall by W L Gore & Associates, Inc., reported 2026-07-08, distributed nationwide. Due to catheter separation
| Recall number | Z-2672-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | W L Gore & Associates, Inc., Flagstaff, AZ, United States |
| Recall initiated | 2026-05-19 |
| Classified | 2026-07-02 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, CA, CH, CN, CY, DE, DK, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, LU, MT, NL, NO, NZ, PL, PT, SA, SE, SK, TW |
| Quantity | 467 devices |
| UPC / GTIN / UDI-DI | 00733132640485, 00733132640539, 00733132644414, 00733132650866, 00733132650873, 00733132650897, 00733132654369, 00733132654376, 00733132654383, 00733132654406, 00733132654413, 00733132654420, 00733132662630, 00733132662647 |
| Serial numbers | 31249440, 31249441, 31249442, 31251480, 31251481, 31251482, 31251484, 31253984, 31253985, 31253986, 31253987, 31253988, 31253989, 31253990, 31256132, 31256133, 31256134, 31256135, 31256136, 31256137, 31256138, 31256139, 31256140, 31256141, 31256961 and 442 more |
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¿ 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.
Reason for recall
Due to catheter separation
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2672-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.