FDA-Device2026-07-08Class IIPROCESSING DEFECT
W L Gore & Associates GORE TAG Thoracic Branch Endoprosthesis recalled for catheter separation risk
What this means
W L Gore & Associates has recalled specific batches of the GORE TAG Thoracic Branch Endoprosthesis Side Branch Component due to a risk of catheter separation during use. This is a surgical implant used to repair certain aortic conditions. The separation could potentially affect the device's ability to function as intended.
- Check if your facility has any of the affected catalog numbers (TSB080806, TSB081006, TSB081206, TSB081506, TSB081706, TSB121506, TSB121706, or TSB122006, with regional suffixes A, E, J, or W).
- If you have affected devices, verify the serial number against the FDA recall list.
- Contact W L Gore & Associates or your device representative for guidance on replacement or return.
- Do not use affected devices if your facility identifies them in inventory.
The agency's original wording
Hazard
Due to catheter separation
Intended for
Adults
Illnesses reported
None reported
Sold states
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, 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.
Affected count
467 devices
Manufactured in
1505 N 4th St, N/A, Flagstaff, AZ, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2672-2026Want us to check the next one for you?
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