GORE TAG Conformable Thoracic Stent Graft TGM262610Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132646920), received between Dec 7, 2020 and May 15, 2026 — classified as 2 deaths, 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Separation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: (DATE: (B)(6) 2026), THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AORTA RUPTURE DUE TO CAR ACCIDENT USING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG DEVICE). CTAG DEVICE WAS DELIVERED TO TARGET LESION AS NORMAL, AND THE POSITIONING WAS ACCURATE DURING THE DEPLOYMENT PROCESS. AFTER THE DEVICE WAS DEPLOYED, IT WAS FOUND THAT THE DELIVERY SYSTEM COULD NOT BE WITHDRAWN. IT WAS CONFIRMED THAT THE ENDO WAS DEPLOYED AND EXPANDED COMPLETELY. AFTER CHANGING THE DSA IMAGING ANGLE, IT WAS FOUND THAT THE LEADING OLIVE TIP CONNECTED TO THE ENDO, THE OLIVE PASSED THROUGH THE BARE WIRE AT THE END OF THE ENDO. DUE TO THE DIAMETER OF THE CATHETER BEING MUCH LARGER THAN THE DIAMETER OF THE BARE WIRE, THE DELIVERY SYSTEM COULD NOT BE MOVED AND WITHDRAWN. AN ACCESS WAS OBTAINED FROM CONTRALATERAL FEMORAL ARTERY OF PATIENT, A SOFT GUIDEWIRE WAS USED INTO THE ADJACENT HOLE OF THE ENDO'S BARE WIRE, A BALLOON AND A CUTTING BALLOON WERE USED TO EXPAND THE HOLE. THE HOLE OF ENDO'S BARE WIRE WAS STRETCHED TO OPEN. THEN, A 10 FR X 70 CM INTRODUCER SHEATH WAS INSERTED, AND THE NICKEL TITANIUM WIRE WAS CLAMPED OFF WITH BIOP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25180980 ↗
• MalfunctionMar 12, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2025, THIS PATIENT UNDERWENT TREATMENT FOR A ZONE 4 DESCENDING THORACIC AORTIC DISSECTION AND WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC). IT WAS REPORTED THAT POST PRIMARY HANDLE DEPLOYMENT AND SECONDARY HANDLE DEPLOYMENT OF THE GRAFT; THE BLUE SECONDARY CONSTRAINING SLEEVE COULD NOT BE PULLED. THE PHYSICIAN PULLED AND MET WITH RESISTANCE AND WOULD NOT RELEASE/DETACH FROM THE GRAFT. MANY ATTEMPTS WERE MADE HOWEVER THE BLUE STRING/LINE. THE PHYSICIAN WENT AHEAD AND OPENED UP THE BACKUP HATCH AND PULLED ON LINE NUMBER 2 WITH A KELLY. THE PHYSICIAN CONTINUED TO PULL ON LINE NUMBER 2; AND AS HE PULLED IT WAS PULLED AT BOTH ENDS AND IT WAS ACTUALLY MOVING THE GRAFT INSIDE OF THE BODY. THE PHYSICIAN DECIDED TO DEPLOY THE REST OF THE DEVICE SO WE COULD GET RID OF THE ANGULATION FIBER AND LOCK PIN. HE THEN PULLED ON THE BLUE LINE AGAIN 2 LEFT IN THE HATCH WHICH CAUSED THE PROXIMAL PORTION OF THE GRAFT TO ANGULATE AND BEING TUGGED OR GETTING PULLED. NOTHING DISTALLY MOVED, JUST ALL PROXIMAL PORTION (LEADING END NOT TRAILING END) OF THE GRAFT MOVED. IT WAS THEN DECIDED TO BALLOON THE DEVICE TO HOPEFULLY BREAK IT OPEN AND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586361 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT DURING IMPLANT OF THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT THE DEVICE WAS ALMOST COMPLETELY PULLED OUT OF THE 3CM OVERLAP ZONE DURING REMOVAL OF THE DEVICE DELIVERY SYSTEM. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WAS IMPLANTED TO BRIDGE ANY GAP AND RELINE THE AREA. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE USED AS BRANCH DEVICES IN THE SUPERIOR MESENTERIC ARTERY, CELIAC ARTERY, RIGHT AND LEFT RENAL ARTERIES. A GORE® TRI LUMEN CATHETER WAS USED TO GAIN THROUGH AND THROUGH WIRE ACCESS TO THE BRANCH ARTERIES. THE PROCEDURE WAS COMPLETED WITH GOOD TECHNICAL RESULTS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT AWOKE AND HAD NO FEELING IN HIS LEGS. THE PATIENT UNDERWENT PLACEMENT OF A SPINAL DRAIN. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE PARAPLEGIA. THE PATIENT IS BEING MONITORED IN THE INTENSIVE CARE UNIT (ICU) AND WAS REPORTED TO HAVE STARTED REGAINING MOVEMENT IN HIS RIGHT LEG AN

  Patient problems: Paraplegia

  MAUDE report 19767736 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A TRAUMA TO THE LEFT SUBCLAVIAN ARTERY AND WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC) THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT WAS HOSPITALIZED FOR TREATMENT OF A DOG BITE. AT THIS TIME THE PATIENT HAD A FULL COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED. UPON REVIEW OF THE CT, THE PHYSICIAN REPORTED THE PROXIMAL EDGE OF THE CTAG-AC DEVICE LOOKED IRREGULAR AND THE PATIENT MAY REQUIRE REINTERVENTION FOR A POSSIBLE BYPASS PROCEDURE. ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT THE PATIENT HAS AN AORTOESOPHAGEAL FISTULA (AEF), A MEDIASTINAL HEMATOMA AND A SUSPECTED INFECTION OF THE CTAG-AC DEVICE. ADDITIONALLY, THE PHYSICIAN REPORTS THE PATIENT HAS A HISTORY OF BACTEREMIA. THE PHYSICIAN BELIEVES THE INFECTION IS RELATED TO MULTIPLE ORTHOPEDIC HARDWARE IMPLANT PROCEDURES THE PATIENT HAS UNDERGONE, AND DOES NOT BELIEVE THE INFECTION WAS CAUSED BY THE GORE DEVICE. THERE IS NO ALLEGATION OF DEFICIENCY OF THE GORE DEVICE. THERE IS NO REINTERVENTION PLANNED FOR THE PATIENT AND THE PHYSICIAN DOES NOT HAVE A POSITIVE OUTCOME FOR THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17572391 ↗
• InjuryAug 1, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM. A REPRESENTATIVE FROM ANOTHER COMPANY USED IVUS TO LOCATE THE CELIAC AND SMA, AND THE PROCEDURE WAS BASED ON THOSE MEASUREMENTS. WHEN THE PHYSICIAN IMPLANTED THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, IT WAS DISCOVERED THAT THE MEASUREMENTS WERE WRONG, AND THE DEVICE COVERED BOTH ARTERIES. THE PHYSICIAN USED A BALLOON TO PUSH THE GRAFT UP, UNCOVERING THE ARTERIES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17438113 ↗
• MalfunctionSep 2, 2022Mechanical Problem; Mechanical Problem

  ON (B)(6).2022, THE PATIENT WAS TREATED FOR A DISSECTION OF THE THORACIC AORTA. THE PHYSICIAN IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PRIMARY DEPLOYMENT AND SECONDARY DEPLOYMENT BOTH WORKED AS EXPECTED, BUT WHEN THE PHYSICIAN TURNED THE RED KNOB FOR THE LOCKWIRE, IT BROKE. THE FSA HAD NOT YET ARRIVED IN THE OR, SO THE CARDIAC SURGEON ELECTED TO PULL THE DEVICE OUT, RATHER THAN TROUBLESHOOT. TWO OTHER GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEMS WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349682 ↗
• InjuryAug 4, 2022Malposition of Device; Malposition of Device

  ON (B)(6) 2022, THIS PATIENT UNDERWENT EMERGENCY ENDOVASCULAR TREATMENT OF A TRAUMATIC THORACIC AORTIC TRANSECTION RESULTING FROM A MOTOR VEHICLE ACCIDENT. A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL WAS INSERTED AND ADVANCED TO JUST BELOW THE CAROTID ARTERY. THE PROXIMAL UNCOVERED STENT APICES WERE PLACED AT THE OSTIUM OF THE LEFT COMMON CAROTID ARTERY, AND THE STENT GRAFT WAS DEPLOYED. HOWEVER, THE FABRIC SLEEVE OF THE DEVICE FULLY COVERED THE 9MM OSTIUM OF THE CAROTID ARTERY AFTER DEPLOYMENT, AND IMPEDED FLOW INTO THE LEFT COMMON CAROTID ARTERY. TO TREAT, THE PHYSICIAN ADVANCED A MOB CATHETER AND INFLATED IT AT THE PROXIMAL AND MIDDLE PORTIONS OF THE STENT GRAFT AND WAS ABLE TO PULL THE STENT GRAFT DISTAL TO UNCOVER THE LEFT COMMON CAROTID ARTERY AND RESTORE BLOOD FLOW. THE PATIENT TOLERATED THE PROCEDURE. THE FSA NOTED THAT THE SLEEVE AT THE PROXIMAL END OF THE STENT GRAFT SEEMED LONGER THAN 4MM. THE REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. A RESPONSE REGARDING THIS EVENT WAS NOT REQUESTED BY THE PHYSICIAN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15164315 ↗
• DeathJul 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, THIS PATIENT PRESENTED AT THE HOSPITAL VIA AMBULANCE FROM A MOTOR VEHICLE ACCIDENT AND UNDERWENT ENDOVASCULAR TREATMENT OF A TRAUMATIC TRANSECTION. IT WAS REPORTED THE PATIENT HAD SUFFERED A TREMENDOUS AMOUNT OF BLOOD LOSS PRIOR TO IMPLANT. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ADVANCED WITHIN THE TRUE LUMEN AND DEPLOYED TO 50%; UPON DOING SO THE PATIENT¿S BLOOD PRESSURE DROPPED; COMPLETE DEPLOYMENT WAS THEN EXECUTED AND THE DEVICE WAS ANGULATED PROXIMALLY TO OBTAIN BETTER SEAL DUE TO A BIRD BEAK ALONG THE GREATER CURVE. IT WAS REPORTED THAT THE PATIENT WAS ALREADY RECEIVING CHEST COMPRESSIONS DURING FULL DEPLOYMENT OF THE DEVICE. THE DELIVERY CATHETER WAS REMOVED FROM THE PATIENT AND CHEST COMPRESSIONS WERE CONTINUED. THE PATIENT WAS ADMINISTERED INTRACARDIAC EPINEPHRINE DURING THIS TIME AND CHEST COMPRESSIONS WERE CONTINUED FOR APPROXIMATELY 38 MINUTES. THE PATIENT WAS UNABLE TO BE STABILIZED AND EXPIRED. THE PHYSICIAN REPORTS THE CAUSE OF DEATH WAS GRADE 4 BLUNT AORTIC INJURY AND BLOOD LOSS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15013200 ↗
• MalfunctionAug 23, 2021Break; Break

  ON (B)(6) 2020, DURING AN ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING A GORE® TAG® THORACIC ENDOPROSTHESIS, IT WAS REPORTED THAT THE DEPLOYMENT KNOB SEEMED TO "SNAP OFF AND NOTHING HAPPENED". THE DEVICE DID NOT DEPLOY. THE PHYSICIAN WAS ABLE TO PULL THE DEVICE BACK INTO THE SHEATH AND REMOVE THE DEVICE FROM THE PATIENT. ANOTHER DEVICE WAS THEN USED SUCCESSFULLY. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THERE APPEARED TO BE FRAYED DEPLOYMENT LINES AT THE LEADING END OF THE DELIVERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356043 ↗
• DeathDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MDT FORM# (B)(4): ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THE PATIENT EXPIRED ON (B)(6) 2020. IT IS UNKNOWN IF THE DEVICE WAS IMPLANT OR EXPLANTED.

  Patient problems: No Code Available

  MAUDE report 10960670 ↗

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