GORE TAG Conformable Thoracic Endoprosthesis TGU212110Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132617777), received between Jul 23, 2018 and Nov 17, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, PATIENT UNDERWENT AN THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS. ON (B)(6) 2025, PATIENT CALLED STATING THE DEVICE WAS DEFECTIVE ACCORDING TO HIS CURRENT PHYSICIANS AND THAT IT NEEDS TO BE EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568411 ↗
• MalfunctionMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG) TO TREAT AN AORTIC TRANSECTION. IT WAS REPORTED THAT THE DEPLOYMENT OF THE CTAG WAS COMPLETED SUCCESSFULLY AND THERE WAS NO HARM DONE TO THE PATIENT. UPON REMOVAL OF THE CATHETER, THE OLIVE TIP WAS CAUGHT IN THE VALVE OF THE COOK 18F INTRODUCER SHEATH. THE SURGEON USED FORCE TO ATTEMPT TO PULL THE CATHETER FROM THE INTRODUCER SHEATH AND THE OLIVE TIP BECAME DETACHED FROM THE CATHETER AND REMAINED IN THE SHEATH. THE PROCEDURE WAS COMPLETED WITH THE CTAG CATHETER STILL ON THE WIRE AND THE TIP STILL STUCK IN THE SHEATH. AFTER A COMPLETION ANGIOGRAM WAS PERFORMED, THE PHYSICIAN REMOVED THE COOK 18F SHEATH WITH THE CTAG CATHETHER AND AMPLATZ SUPER STIFF GUIDEWIRE ALL AS ONE UNIT. THE PHYSICIAN THEN SUCCESSFULLY CLOSED THE ACCESS SITE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9793203 ↗
• InjuryOct 4, 2019Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  ON (B)(6) 2019 THE PATIENT WAS BEING TREATED FOR A PENETRATING AORTIC ULCER (PAU) USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED THAT THE PHYSICIAN USED A NON-GORE (COOK) SHEATH AND DURING REMOVAL OF THE DELIVERY SYSTEM, THE DISTAL OLIVE TIP CAUGHT THE SHEATH AND DISLODGED. THE PHYSICIAN REPORTED RESISTANCE IN TRYING TO GET PAST THE VALVE IN THE COOK SHEATH. WHEN THE PHYSICIAN PULLED AGAINST THE RESISTANCE, THE OLIVE TIP CAME OFF IN THE SHEATH. THE PHYSICIAN REPORTEDLY PUSHED THE WIRE FORWARD AND THAT DISLODGED THE OLIVE FROM THE SHEATH AND DOWN INTO THE PATIENT¿S GROIN. REPORTEDLY A CUT DOWN INSTEAD OF PERCUTANEOUS CLOSURE WAS PERFORMED TO ENSURE THE OLIVE DID NOT GET CAUGHT ON PRE-CLOSE SUTURES. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159387 ↗
• InjuryFeb 27, 2019Off-Label Use; Off-Label Use

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR INFRARENAL AORTIC DISSECTION AND WAS IMPLANTED WITH A CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESES (CTAG). IT WAS REPORTED THAT THERE WAS PARTIAL UNINTENTIONAL COVERAGE OF THE RIGHT RENAL ARTERY. THERE WAS NO DEFICIENCY OF THE DEVICE REPORTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, THE PATIENT WAS REPORTED TO BE EXPERIENCING RENAL FUNCTION. COMPUTED TOMOGRAPHY WAS PERFORMED THIS DATE AND SHOWED COMPLETE COVERAGE OF THE RIGHT RENAL ARTERY. THE PATIENT UNDERWENT REINTERVENTION AND THE WAS CONVERTED TO OPEN REPAIR AND THE CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESES WAS EXPLANTED. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Vascular Dissection

  MAUDE report 8376343 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A COARCTATION OF THE THORACIC AORTA AND A DESCENDING THORACIC AORTIC DISSECTION WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TGU212110/16460122). IT WAS REPORTED THE PATIENT HAD A FEVER PRIOR TO THE IMPLANT PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018, THE PATIENT UNDERWENT TREATMENT FOR A PSEUDOANEURYSM DISTAL TO THE IMPLANTED GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. THERE WAS A POSSIBLE INFECTION STILL PRESENT. THE PHYSICIAN IMPLANTED AN ADDITIONAL GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (THU212110/16576646A). THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH FOR THE POSSIBLE INFECTION.

  Patient problems: Vascular Dissection

  MAUDE report 7713157 ↗

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