GORE TAG Thoracic Endoprosthesis TGT3110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132613618), received between Jun 25, 2020 and Jun 25, 2020 — 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 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT TREATMENT FOR A DISSECTING THORACIC AORTIC ANEURYSM. A TOTAL ARCH REPLACEMENT (TAR) PROCEDURE AND OPEN STENT PROCEDURE WAS PERFORMED, AND TWO GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON MAY 15, 2020, FOLLOW-UP COMPUTED TOMOGRAPHY IDENTIFIED A DISSECTION FROM THE DISTAL END OF THE GORE® TAG® THORACIC ENDOPROSTHESIS AND THE LEAK FROM THE ANASTOMOSIS SITE OF THE RECONSTRUCTED THE LEFT COMMON CAROTID ARTERY IN THE TAR PROCEDURE (OUTSIDE OF THE GORE® TAG® TREATMENT AREA). 3D RECONSTRUCTION ILLUSTRATING BOTH PROXIMAL AND DISTAL FALSE LUMEN PROFUSION. 3D RECONSTRUCTION ILLUSTRATING CONTRAST POOLING AROUND THE LSA AND THE LCCA. 3D RECONSTRUCTION ILLUSTRATING FALSE LUMEN PERFUSION. ON (B)(6) 2020, THE PATIENT UNDERWENT A REINTERVENTION USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL® SYSTEM. FIRST, A LEFT AXILLARY ARTERY ¿ RIGHT AXILLARY ARTERY ¿ LEFT COMMON CAROTID ARTERY BYPASS PROCEDURE WAS PERFORMED. THEN, A TGMR373715J WAS IMPLANTED PROXIMALLY OF THE PREVIOUS IMPLANTED TAG® DEVICE TO SOLVE THE LEAK FROM THE ANASTOMOSIS SITE OF THE RECONSTRUCTED LEFT COMMON CAROTID ARTERY. THEN A

  Patient problems: Vascular Dissection

  MAUDE report 10197406 ↗

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-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0291-2021 · 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-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm
• Z-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm