W L Gore & Associates, Inc. recalls GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repai…
- Recall date
- September 25, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0048-2018
- FDA classification
- Class II
- Brand / firm
- W L Gore & Associates, Inc.
- Sold / distributed
- Worldwide.
Why it was recalled
Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
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