FDA recall Z-0048-2018

W L Gore & Associates, Inc. · Class II · device

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 for recall

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

Distribution

Worldwide.

Key facts

Status: Terminated
Initiation date: 2017-09-25
Report date: 2017-11-01
Termination date: 2019-08-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Flagstaff, AZ, United States

Primary source

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