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GORE TAG Thoracic Branch Endoprosthesis
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MEDICAL DEVICE RECALLMODERATE

GORE TAG Thoracic Branch Endoprosthesis

W.L. Gore & Associates is recalling its GORE TAG Thoracic Branch Endoprosthesis due to a device defect.

What to do

Do not use this product. Return the device to the manufacturer. Follow the instructions provided in the FDA recall notice or by W.L. Gore & Associates for return and remediation. Healthcare providers should check their inventory and identify affected units using the full catalog number list available on the agency's recall page. Patients should contact their healthcare provider for guidance.

Recalled
Listed
Updated
Recall No.
Z-2672-2026
Agency
FDA
Firm
W L Gore & Associates, Inc.
Recall ID
99140
Status
ONGOING

Recall at a glance

Quantity recalled
467 devices

Why it was recalled

W.L. Gore & Associates is recalling its GORE TAG Thoracic Branch Endoprosthesis due to a device defect. This recall affects all catalog numbers, sizes, and regional variations of the device. The product is used in endovascular repair of lesions of the aortic arch and descending thoracic aorta. The specific defect or malfunction has not been detailed in the summarized information, but the recall has been initiated to address potential risks to patients. For a complete list of affected catalog numbers and detailed product information, please refer to the FDA recall notice.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

ProductUDI-DI
Taiwa00733132654369, 31602664, 00733132662630, 31421864, 31421865, 31421870, 31432339, 31432340, 31440637, 31440638, 31440639, 31440640, 31440641, 31440642, 31462061, 31462062, 31462063, 31462064, 00733132650866, 31530086
Taiwan: TSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W TheTSB081006A, 00733132654369, TSB081006J, 00733132662630, TSB081006W, 00733132650866, TSB081206A, 00733132654376, TSB081206E, 00733132640485, TSB081206J, 00733132662647, TSB081206W, 00733132650873, TSB081506A, 00733132654383, TSB081506W, 00733132644414, TSB121506A, 00733132654406, TSB121506W, 00733132650897, TSB121706A, 00733132654413, TSB122006A, 00733132654420, TSB122006E, 00733132640539

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-07 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification