FDA-Device2017-11-01Class II

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

W L Gore & Associates, Inc.
Hazard

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

Sold states
Worldwide.
Affected count
12,197units
Manufactured in
1500 N Fourth St., N/A, Flagstaff, AZ, United States
Products
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0048-2018

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