GORE TAG Thoracic Endoprosthesis TGT3415Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132613649), received between Aug 22, 2022 and Jun 5, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING AORTA ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESIS. ON AN UNKNOWN DATE, IT WAS REVEALED ANEURYSMALIZATION ON THE DISTAL SIDE OF THE DEVICE ON A CT IMAGE. THE PATIENT REPORTEDLY HAD POOR RENAL FUNCTION AND COULD NOT PERFORM ANGIOGRAPHY. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED, AN ADDITIONAL STENT GRAFT WAS PLACED DISTALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 22155468 ↗
• InjuryJan 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RUPTURE OF TYPE B ACUTE AORTIC DISSECTION USING GORE® TAG® THORACIC ENDOPROSTHESIS. IN (B)(6) 2016, A REINTERVENTION WAS PERFORMED TO TREAT A PROXIMAL TYPE I ENDOLEAK, ADDITIONAL STENT GRAFT WAS PLACED PROXIMALLY. ON AN UNKNOWN DATE, AN AORTA EXPANSION AT THE DISTAL SIDE OF THE DEVICE AND A DISTAL TYPE I ENDOLEAK WERE OBSERVED. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED, ADDITIONAL STENT GRAFTS WERE PLACED DISTALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21108795 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING A GORE® TAG® THORACIC ENDOPROSTHESIS. ON AN UNKNOWN DATE, A FOLLOW-UP EXAMINATION REPORTEDLY REVEALED ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). NO ENDOLEAK WAS OBSERVED DURING THE EXAMINATION. IT WAS REPORTED THE PATIENT ALSO DEVELOPED OCCASIONAL HEMOPTYSIS. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED. AN INTRA-OPERATIVE ANGIOGRAPH SHOWED NO ENDOLEAK. TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG-AC) WERE IMPLANTED AS PROXIMAL AND DISTAL EXTENSION OF THE EXISTING GORE® TAG® THORACIC ENDOPROSTHESIS. AFTER TOUCH-UP BALLOONING WAS PERFORMED, AN ANGIOGRAPH REPORTEDLY REVEALED THE PROXIMAL CTAG-AC MOVED DISTALLY ABOUT 2CM UPON DEPLOYMENT. THE CAUSE OF THE ALLEGED DEVICE MOVEMENT IS UNKNOWN, AND NO ISSUES WERE REPORTED WITH HANDLING AND OPERATING THE DEVICE PER THE INSTRUCTIONS FOR USE. ACCORDING TO THE REPORT, THE PROXIMAL CTAG-AC WAS POSITIONED AT NEARLY SAME LEVEL AS THE PROXIMAL END OF THE EXISTING GORE® TAG® THORACIC ENDOPROSTHESIS. NO ADDITIONAL TREATMENT WAS PERFORMED, AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE

  Patient problems: Aneurysm expansion

  MAUDE report 15265719 ↗

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-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