GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers...
Reason for Recall / Hazard
Due to catheter separation
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Flagstaff |
| State | AZ |
| Event id | 99140 |
| Address 1 | 1505 N 4th St |
| Address 2 | N/A |
| Code info | Catalog Number / UDI-DI Code: TSB081006A (00733132654369) Serial Numbers: 31602664 Catalog Number / UDI-DI Code: TSB081006J (00733132662630) Serial Numbers: 31421864 31421865 31421870 31432339 31432340 31440637 31440638 31440639 31440640 31440641 31440642 31462061 31462062 31462063 31462064 Catalog Number / UDI-DI Code: TSB081006W (00733132650866) Serial Numbers: 31530086 Catalog Number / UDI-DI Code: TSB081206A (00733132654376) Serial Numbers: 31251480 31251481 31251482 31251484 31256961 31256963 31272521 31272522 31272523 31272525 31272526 31272527 31272528 31272529 31272530 31272531 31272533 31272534 31277206 31277207 31277208 31277209 31277210 31280248 31280249 31280250 31280251 31280252 31280254 31280255 31280256 31280257 31289924 31289925 31289926 31289928 31289929 31290547 31290548 31290549 31290550 31301117 31301118 31307814 31312365 31312366 31312367 31319612 31319613 31332034 31332036 31342363 31342364 31345617 31366643 31387545 31395549 31395550 31397877 31397878 31407669... [TRUNCATED] |
| Postal code | 86004-5867 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 467 devices |
| Reason for recall | Due to catheter separation |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260519 |
| Initial firm notification | Letter |
| Center classification date | 20260702 |
Overview
- Recalling FirmW L Gore & Associates, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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, Austria, Canada, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Monaco, Malta, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovakia, Sweden, and Taiwan.