GORE TAG Conformable Thoracic Endoprosthesis TGU312610Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132618040), received between Jun 18, 2019 and Jun 18, 2019 — classified as 1 injury.

6 other recalls cover devices cleared under the same FDA submission (P040043); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. FOLLOW UP IMAGING DATED (B)(6) 2017 SHOWED THE ANEURYSM MEASURED 45 MM. FOLLOW UP IMAGING ON AN UNKNOWN DATE IN (B)(6) 2018 SHOWED THE ANEURYSM MEASURED 54 MM, HOWEVER, THE REASON FOR THE ANEURYSM GROWTH WAS NOT REPORTED TO GORE. ON (B)(6) 2018, THE PATIENT UNDERWENT A CONVERSION TO OPEN REPAIR WHEREBY THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE EXPLANTED. A CARDIOPULMONARY BYPASS WAS ALSO PERFORMED.

  Patient problems: No Code Available

  MAUDE report 8707868 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040043. One submission often covers many models, so check the product and lot details in each record.

• Z-0291-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-2052-2020 · Dec 17, 2019 · Terminated
  Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
• Z-0048-2018 · Sep 25, 2017 · Terminated
  GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
• Z-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
• Z-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm