Medical device recalls Moderate risk

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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