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W L Gore & Associates, Inc. recalls GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular r
Recalled November 1, 2017 · FDA recall Z-0048-2018 · W L Gore & Associates
Hazard
Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure. · FDA Class II
Units
12,197units
Sold at
Worldwide.
Description
Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
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(s)
W L Gore & Associates, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →