GORE TAG Conformable Thoracic Endoprosthesis TGU262610Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132617784), received between Mar 27, 2019 and Jul 2, 2025 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A PENETRATING AORTIC ULCER WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS DEVICE. THE PATIENT TOLERATED THE PROCEDURE. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 23.1MM. THE FOLLOW UP CTA SHOWED THAT FROM (B)(6)2013 TO (B)(6) 2018 THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED FROM 25MM TO 41MM. REPORTEDLY, NO TREATMENT WAS PERFORMED.

  Patient problems: Aneurysm expansion

  MAUDE report 22391672 ↗
• InjuryDec 17, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2015, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 43.5MM. A TGU262610/ 13983463 WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM, AND A TGU262610/13601564 WAS IMPLANTED TO TREAT RIGHT COMMON AND INTERNAL ILIAC ARTERIES ANEURYSM. REPORTEDLY, THE PATIENT HAD A MODERATE-SIZED AORTIC ANEURYSM AND A HUGE RIGHT COMMON ILIAC ARTERY ANEURYSM. ADDITIONALLY, THE PATIENT HAD A HISTORY OF THROMBOSED LEFT COMMON ILIAC ARTERY ANEURYSM WITH THROMBOSIS OF THE LEFT INTERNAL ILIAC AND THE PROXIMAL LEFT EXTERNAL ILIAC ARTERIES. THIS HAS RESULTED IN SEVERE LIFESTYLE LIMITING LEFT LEG CLAUDICATION. ALSO, ON (B)(6) 2015, THE RIGHT TO LEFT FEMORAL-FEMORAL BYPASS PROCEDURE WAS DONE WITH 8MM PROPATEN RINGED GORE-TEX GRAFT. ACCORDING TO THE PHYSICIAN, THE ANEURYSM HAD A VERY LONG NECK AND THE RIGHT COMMON ILIAC ARTERY HAD A HUGE ANEURYSM, AT LEAST 4CM AND THE INTERNAL AND EXTERNAL ILIAC ARTERIES WERE WIDELY PATENT, BUT RATHER TORTUOUS. THE ANE

  Patient problems: Aneurysm; No Code Available

  MAUDE report 9481985 ↗
• DeathNov 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED THE PATIENT EXPIRED ON (B)(6) 2019. NO ADDITIONAL INFORMATION RELATED TO THIS EVENT WILL BE MADE AVAILABLE TO GORE. THEREFORE, FURTHER INVESTIGATION IS NOT POSSIBLE.

  Patient problems: No Information

  MAUDE report 9365657 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6)2018 A PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC DISSECTION, ZONE 2, WITH MAXIMUM AORTIC DIAMETER OF 50.2MM USING TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND ONE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AS DISTAL EXTENSION TO AORTIC COMPONENT. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. ON (B)(6), 2018 A CT REVEALED THE MAXIMUM AORTIC DIAMETER WAS 52MM. ON (B)(6) 2018 THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE WHEREBY AN ADDITIONAL DEVICE WAS IMPLANTED TO EXTEND THE TREATMENT. THIS WAS DUE TO A DESCENDING THORACIC ANEURYSM. FOLLOWING THE PROCEDURE A THROMBOSIS OF THE LEFT EXTERNAL ILIAC AND COMMON FEMORAL ARTERY OCCURRED. THIS WAS STATED TO BE PROCEDURE RELATED. ON (B)(6) 2018 A THROMBECTOMY OF THE LEFT EXTERNAL ILIAC AND COMMON FEMORAL ARTERY WAS PERFORMED. IT IS NOT KNOWN WHY THE VESSELS THROMBOSED. ON (B)(6) 2019 IT WAS REPORTED A GORE SHEATH WAS ASSOCIATED WITH THE THROMBOSIS. THIS INFORMATION WILL BE REPORTED SEPARATELY.

  Patient problems: Aneurysm

  MAUDE report 8457790 ↗

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