Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0048-2018 — GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.

U.S. FDA — Device Enforcement · United States · 2017-09-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0048-2018
Date of alert
2017-09-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
W L Gore & Associates, Inc.
Product category
device
Product type
Devices
Reported risk: Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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