GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall
W. L. Gore & Associates is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to risk of catheter separation during deployment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a cardiovascular implant device with a mechanical failure hazard (catheter separation) that could result in serious injury or device malfunction during a critical surgical procedure. Class II recalls involving structural or functional defects in implantable devices where injury risk exists warrant a Severe rating.
Plain-English summary
W. L. Gore & Associates, Inc. is recalling the GORE TAG Thoracic Branch Endoprosthesis Side Branch Component, a medical device used for endovascular repair of lesions of the aortic arch and descending thoracic aorta. The recall affects 467 devices distributed worldwide, including throughout the United States (Puerto Rico), Canada, and numerous other countries across Europe, Asia, Australia, and the Middle East.
The devices are being recalled due to the risk of catheter separation during deployment. This hazard could compromise the proper placement and function of the endoprosthesis.
Healthcare providers and patients who have received this device should contact W. L. Gore & Associates or their physician for further guidance. The specific affected catalog numbers and serial numbers are documented in the FDA recall notice for identification purposes.
The recalled product
- 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…
- Manufacturer
- W L Gore & Associates, Inc.
- Affected units
- 467
Distribution
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