GORE TAG Thoracic Endoprosthesis Recalled for Incomplete Deployment Risk
W.L. Gore & Associates is recalling 12,197 GORE TAG Thoracic Endoprosthesis units worldwide due to a risk of incomplete or partial deployment during endovascular procedures.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incomplete deployment of a medical device) where specific injury reports are not detailed in the provided source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
W.L. Gore & Associates, Inc. is recalling 12,197 units of the GORE TAG Thoracic Endoprosthesis, Conformable. The device is intended for endovascular repair of all lesions of the descending thoracic aorta. The recall is being conducted worldwide.
The recall is due to the potential for incomplete and/or partial deployment of the device during the endovascular procedure. This issue could affect the intended function of the endoprosthesis.
Healthcare providers and patients who have received this device should contact W.L. Gore & Associates, Inc. for further instructions on how to proceed. The specific serial numbers affected are listed in the official recall documentation.
The recalled product
- Product
- GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Vascular Graft
- Affected units
- 12,197
Distribution
Distribution scope not specified by the agency.
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