Recall Z-0048-2018— W L Gore & Associates, Inc.

Name: FDA recall Z-0048-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-25

Class II · Terminated

Class II FDA medical device recall by W L Gore & Associates, Inc., initiated 2017-09-25, terminated 2019-08-27. FDA's recall record names no specific 510(k) clearance for this event. Product: GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.. Reason: Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure..

Recalling firm: W L Gore & Associates, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-09-25
Terminated: 2019-08-27
Firm location: Flagstaff, AZ, United States

Product description

GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.

Reason for recall

Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.

Data sourced from openFDA. This site is unofficial and independent of the FDA.