GORE TAG Conformable Thoracic Endoprosthesis TGU373720Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132618194), received between Jun 3, 2019 and Sep 15, 2025 — classified as 3 deaths, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2014, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DESCENDING ANEURYSM, UTILIZING CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS. ON AN UNKNOWN DATE, A TYPE 1A ENDOLEAK WAS OBSERVED DURING A FOLLOW-UP IMAGING. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION SURGERY TO TREAT THIS ENDOLEAK IN WHICH ADDITIONAL DEVICES (GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS) WERE IMPLANTED PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER PATIENT INFORMATION OR IMAGES ARE AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 23059740 ↗
• InjuryDec 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING A CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS. ON (B)(6) 2022, DURING A FOLLOW UP, THE PHYSICIAN DISCOVERED A PSEUDOANEURYSM AT THE PROXIMAL END OF THE BARE STENT ON THE LATERAL SIDE OF THE CTAG DEVICE. THE PHYSICIAN BELIEVES THE PSEUDOANEURYSM MAY BE RELATED TO THE BARE STENT. REPORTEDLY, THE PHYSICIAN PLANS TO DO A REINTERVENTION. IMAGING EVALUATION: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING THERE APPEARS TO BE A PSEUDOANEURYSM AT THE LEVEL OF THE BARE METAL STENT PORTION OF THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE PSEUDOANEURYSM IS ~11MM IN LENGTH. THE PSEUDOANEURYSM IS AT THE LOCATION WHERE THE BARE METAL STENT ROWS ONE AND A PORTION OF ROW TWO COME TOGETHER.

  Patient problems: Pseudoaneurysm

  MAUDE report 16018181 ↗
• DeathFeb 18, 2021Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Separation; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED TO GORE ON (B)(6) 2021 THAT THIS PATIENT UNDERWENT REINTERVENTION FOR AN AORTIC ANEURYSM ON (B)(6) 2019 WHEREBY A CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS WAS IMPLANTED. IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE THE LEADING OLIVE OF THE CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SEPARATED AND CAUSED PATIENT DEATH. THROUGH FURTHER INVESTIGATION, THE FOLLOWING INFORMATION WAS REPORTED TO GORE: THIS PATIENT HAD PREVIOUSLY UNDERWENT REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON (B)(6) 2012. IT WAS ALSO REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS ALSO IMPLANTED WITH A NON-GORE AORTIC CUFF. DURING THE REINTERVENTION ON (B)(6) 2019, IT WAS NOTED THAT THE NON-GORE AORTIC CUFF HAD MIGRATED DISTALLY. IT WAS REPORTED THAT DURING THE REINTERVENTION WHEN THE DELIVERY CATHETER OF THE FIRST CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS WAS BEING REMOVED, THE HOSPITAL STAFF THAT WAS ATTEMPTING TO REMOVE THE CATHETER FELT A SUBSTANTIAL AMOUNT OF RESISTANCE. IT WAS FURTHER REPORTED THAT HOSPITAL STAFF CONTINUED TO PULL AGAINST THE RESISTANCE WITH ENOUGH FORCE TO KINK THE SUPER STIFF GUIDEWIRE, FINALLY REMOVING THE CATHETER

  Patient problems: Death; Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 11346241 ↗
• DeathMar 5, 2020Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR [TEVAR] AND LEFT CAROTID TO SUBCLAVIAN ARTERY BYPASS ON (B)(6) 2016 WHEREBY THREE AORTIC TAG THORACIC ENDOPROSTHESES (CTAG) WERE IMPLANTED. A LAWSUIT SUBSEQUENTLY WAS FILED BY THE ESTATE OF (B)(6). PLAINTIFFS WERE DR. (B)(6) AND (B)(6) PHYSICIANS. THE LAWSUIT COMPLAINT ALLEGES THAT ON (B)(6) 2016, (B)(6) [DECEDENT] ¿WAS A PASSENGER IN A MOTOR VEHICLE WHICH WAS INVOLVED IN A COLLISION.¿ AT (B)(6) HOSPITAL, (B)(6), A CT CHEST REVEALED ¿AN INTIMAL FLAP EXTENDING FROM THE AORTIC ARCH POSTERIOR TO THE SUBCLAVIAN ARTERY ORIGIN DOWN THROUGH THE DESCENDING THORACIC AORTA AND INTO THE ABDOMINAL AORTA TO THE LEVEL OF THE AORTIC BIFURCATION. CONTRAST [WAS] SEEN BETWEEN THE TRUE AND FALSE LUMENS. THERE [WAS] ANEURYSMAL DILATATION OF THE DESCENDING THORACIC AORTA WHICH MEASURE[D] TO 6.5 CM TRANSVERSE X 5.3 CM AP.¿ IMPRESSION: ¿TYPE B AORTIC DISSECTION EXTENDING FROM THE AORTIC ARCH POSTERIOR TO THE SUBCLAVIAN ARTERY ORIGIN DOWN THROUGH THE DESCENDING THORACIC AORTA AS DESCRIBED ABOVE.¿ ¿¿ TRANSVERSE AORTIC ARCH JUST PROXIMAL TO THE LEFT SUBCLAVIAN ARTERY AND DISTAL TO THE LEFT COMMON CAROTID ARTERY MEASURED 33 TO 34 MI

  Patient problems: Aortic Dissection; Death; Occlusion

  MAUDE report 9794917 ↗
• DeathFeb 4, 2020Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2020, A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS TO BE IMPLANTED DURING TREATMENT OF A THORACIC AORTA DISSECTION. WHEN THE DEVICE WAS ADVANCED TO THE TARGET LESION THROUGH THE GORE DRYSEAL SHEATH WITH HYDROPHILIC COATING(DSL2428), THE PHYSICIAN INITIATED THE DEPLOYMENT LINE , THE PROXIMAL END OF THE DEVICE EXPANDED AND DURING THIS PROCESS ,NO ANY RESISTANCE COULD BE FELT. WHEN THE PHYSICIAN CONTINUOUSLY PULLED OUT THE DEPLOYMENT LINE, THE DISTAL END OF THE DEVICE DIDN¿T EXPAND . AFTER THE WHOLE DEPLOYMENT LINE WAS PULLED OUT, THE DISTAL END OF THE DEVICE WAS STILL CONSTRAINED. THE PHYSICIAN DECIDED TO RETRACT THE DEVICE . THE CONSTRAINED PART COULD BE PULLED BACK INTO THE SHEATH, BUT THE EXPANDED PART COULDN¿T BE PULLED BACK INTO THE SHEATH, THE PHYSICIAN RETRACTED THE DEVICE AND SHEATH IN TANDEM. DURING THE REMOVAL, THE LEADING OLIVE WAS DETACHED FROM THE DELIVERY SYSTEM BECAUSE OF EXCESSIVE FORCE AND THE COMMON ILIAC ARTERY WAS RUPTURED BY THE DEVICE. THE PATIENT DIED ON JAN 13, 2020 BECAUSE OF EXCESSIVE LOSS OF BLOOD. IT WAS REPORTED THAT THERE WAS ADEQUATE ILIAC AND FEMORAL ACCESS AND NO REPORTED TORTUOSITY DURING THE PROCEDURE.

  Patient problems: Death; Exsanguination; Perforation of Vessels

  MAUDE report 9663448 ↗
• MalfunctionJun 3, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. A 22 FR. GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ADVANCEMENT OF THE DEVICE ALONG SIDE A PIG TAIL CATHETER. THE DEVICE WAS SUCCESSFULLY DEPLOYED AND WHEN WITHDRAWING THE DELIVERY CATHETER, THE OLIVE TIP BECAME WRAPPED AROUND THE PIG TAIL CATHETER AND GOT STUCK ON THE VALVE OF THE SHEATH. IT WAS REPORTED BY THE PHYSICIAN THAT HE PULLED BACK ¿HARD¿ ON THE DELIVER CATHETER, CAUSING THE TIP TO BREAK OFF INSIDE THE SHEATH AND CAUSING DAMAGE TO THE VALVE OF THE SHEATH. THE DELIVERY CATHETER, WITH THE DETACHED OLIVE TIP WERE ALL REMOVED TOGETHER WITH THE SHEATH. A NEW SHEATH WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT RECEIVED 2 UNITS OF BLOOD DUE TO THE UNPLANNED SHEATH REMOVAL. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THERE WAS NO PROBLEM WITH ANY OF THE GORE DEVICES; NOT REMOVING THE PIGTAIL CATHETER PRIOR TO REMOVAL OF THE DELIVERY CATHETER HAD BEEN THE ISSUE.

  Patient problems: Aneurysm

  MAUDE report 8663060 ↗

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