GORE TAG Conformable Thoracic Stent GraftRecalls & reported problems across all models

We found 25 models of GORE TAG Conformable Thoracic Stent Graft by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 325 adverse event reports in the FDA's MAUDE database, received between Aug 5, 2019 and Sep 29, 2026 — classified as 32 deaths, 209 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (31 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GORE TAG Conformable Thoracic Stent Graft problems

GORE TAG Conformable Thoracic Stent Graft models

25 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE TAG Conformable Thoracic Stent Graft TGMR373715

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths32 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR373720

  System, Endovascular Graft, Aortic Aneurysm Treatment
  26 reports
• GORE TAG Conformable Thoracic Stent Graft TGM343415

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths26 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR404010

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths21 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR404020

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death21 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR313110

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths20 reports
• GORE TAG Conformable Thoracic Stent Graft TGM343410

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths18 reports
• GORE TAG Conformable Thoracic Stent Graft TGM454520

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths18 reports
• GORE TAG Conformable Thoracic Stent Graft TGM343420

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths16 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR373710

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths15 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR404015

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths14 reports
• GORE TAG Conformable Thoracic Stent Graft TGM282810

  System, Endovascular Graft, Aortic Aneurysm Treatment
  14 reports
• GORE TAG Conformable Thoracic Stent Graft TGM282815

  System, Endovascular Graft, Aortic Aneurysm Treatment
  12 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR313115

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths11 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR313120

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths11 reports
• GORE TAG Conformable Thoracic Stent Graft TGM262610

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths10 reports
• GORE TAG Conformable Thoracic Stent Graft TGM454515

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths10 reports
• GORE TAG Conformable Thoracic Stent Graft TGM454510

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths8 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR312610

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE TAG Conformable Thoracic Stent Graft TGM212110

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR403415

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE TAG Conformable Thoracic Stent Graft TGM342815

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE TAG Conformable Thoracic Stent Graft TGM453715

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR373115

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE TAG Conformable Thoracic Stent Graft TGM262110

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report

Recent GORE TAG Conformable Thoracic Stent Graft adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940838 ↗
• DeathSep 4, 2026Malposition of Device; Migration

  It was reported that the patient underwent a Frozen Elephant Trunk (FET) procedure on (b)(6) 2026, for treatment of a Type A aortic dissection utilizing a GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG).On August 10, 2026, the Field Sales Associate (FSA) was notified that the patient expired on (b)(6) 2026.Following the procedure, the physician reported concern that the device may have been implanted in the false lumen or, alternatively, may have migrated through a fenestration from the true lumen into the false lumen. The physician stated that the device appeared to be in the false lumen and that mesenteric malperfusion was present. An angiogram reportedly demonstrated no perfusion to the mesenteric vessels. The patient also experienced elevated potassium levels.The physician indicated that it was unclear whether the event represented initial device malposition or distal migration from the true lumen into the false lumen. Any migration distance was unknown. No deployment difficulties were reported. No completion angiogram was performed, and no imaging was available for review. The physician did not specifically attribute the patient's death to the CTA

  Patient problems: Insufficient Information

  MAUDE report 50621371 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  The following was reported from the iMedidata study database:On (b)(6) 2026, a patient was treated for a thoracoabdominal aneurysm following open repair of a dissection using a GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System.On the same day, after the procedure, a stroke was noted. Imaging demonstrated a clinical infarct. No Treatment was given, and the patient recovered (b)(6) 2026.

  Patient problems: Stroke/CVA

  MAUDE report 50501088 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  The following information was reported to Gore through the pivotal study for the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta (ASG device): On (b)(6) 2026, the patient was implanted with GORE® TAG® Conformable Thoracic Stent Graft with Active Control System and the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Aortic Component and Side Branch) to treat a thoracic aneurysm in the descending thoracic aorta. The patient tolerated the procedure. It was reported that follow up images dated (b)(6) 2026, revealed device compression. The event is ongoing.

  Patient problems: Aortic dissection

  MAUDE report 50105884 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED AFTER THE IMPLANT PROCEDURE; THE PATIENT EXPERIENCED WEAKNESS IN THE LEGS AND THAT PROGRESSED INTO LOWER EXTREMITY PARALYSIS. THERE WAS NO INTERVENTION, THE EVENT IS ONGOING. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY TO TREAT THE NEUROLOGICAL DEFICIT. REPORTEDLY A SPINAL DRAIN WAS PLACED PRE-PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 25506746 ↗
• InjuryJun 10, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2025, THE PATIENT UNDERWENT A THORACOABDOMINAL ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM FROM TYPE B DISSECTION (FALSE LUMEN DILATATION) UTILIZING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6), 2025, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6), 2025, UNSCHEDULED FOLLOW-UP VISIT, IT WAS NOTED THAT THERE WAS A TYPE 1B ENDOLEAK WITH PARTIAL THROMBOSIS AND TYPE R OR RETROGRADE FLOW PERFUSED IN THE FALSE LUMEN ADJACENT TO THE THORACIC STENT GRAFT BUT IT WAS PATENT. PATIENT WAS CONTINUED TO BE MONITORED. ON (B)(6), 2026, UNSCHEDULED FOLLOW-UP VISIT, THORACIC STENT GRAFT REMAINED PATENT WITH NO SIGN OF TYPE 1B ENDOLEAK, HOWEVER, IT WAS REPORTED THAT THERE WAS A TYPE III ENDOLEAK BETWEEN THE TWO THORACIC STENT GRAFTS WITH NO DEVICE MIGRATION WITH MILD INCREASED ANEURYSM SAC (SIZE UNKNOWN) REQUIRING REINTERVENTION. ON (B)(6), 2026, PATIENT UNDERWENT REINTERVENTION PROCEDURE WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO REALIGN BOTH STENT GRAFTS AND RESOLVE THE TYPE III ENDOLEAK.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25462296 ↗
• DeathJun 10, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE SUBJECT WAS BEING TREATED FOR AN UNKNOWN ETIOLOGY, UTILIZING THE INVESTIGATIONAL GORE® ASCENDING STENT GRAFT (ASG CLINICAL STUDY 2402). A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL WAS ALSO IMPLANTED DURING THE PROCEDURE. AS PER CLINICAL STUDY DATABASE, IT WAS REPORTED ON THE SAME DAY OF THE PROCEDURE (B)(6) 2026, THE SUBJECT EXPERIENCED AN ACUTE KIDNEY INJURY, TREATMENT INCLUDING RELIEVING MALPERFUSION SURGICALLY. IN ADDITION, SUBJECT ALSO EXPERIENCED A HEMORRHAGE EPISODE ON (B)(6) 2026, WHICH LED TO DEATH. IT IS CURRENTLY UNKNOWN IF THIS DEATH IS RELATED TO ANY POST-MARKET DEVICES. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: Renal Impairment

  MAUDE report 25462009 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) IN COMBINATION WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT THE PROCEDURAL PLAN INITIALLY INCLUDED CONSIDERATION OF THORACIC REPAIR ALONE; HOWEVER, THE TREATING TEAM ELECTED TO PROCEED WITH THORACOABDOMINAL REPAIR USING THE TAMBE SYSTEM. CTAG DEVICES WERE IMPLANTED IN THE THORACIC AORTA, FOLLOWED BY DEPLOYMENT OF THE TAMBE AORTIC COMPONENT AND GORE® EXCLUDER® ILIAC BRANCH AND CONTRALATERAL LEG COMPONENTS. SPECIFIC GORE® VIABAHN® VBX IMPLANT DETAILS WERE NOT AVAILABLE AT THE TIME OF REPORTING. THE PROCEDURE REPORTEDLY PROGRESSED WITHOUT TECHNICAL COMPLICATIONS. NEAR THE CONCLUSION OF THE PROCEDURE, AN INTRAOPERATIVE PRESSURE TEST WAS PERFORMED TO SIMULATE THE IMPACT OF LUMBAR ARTERY COVERAGE. NEUROMONITORING WAS ASSESSED DURING THIS PERIOD, AND NO CHANGES WERE OBSERVED. BASED ON THESE NEUROMONITORING FINDINGS, THE PHYSICIAN PROCEEDED WITH COMPLETION OF THE LEFT ILIAC LIMB. IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT EXPERIENCED

  Patient problems: Ischemia Stroke; Paresis

  MAUDE report 25449456 ↗
• InjuryJun 9, 2026Inadequacy of Device Shape and/or Size; Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM PLACED AS THE DISTAL. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PHYSICIAN NOTICED A TYPE 1B ENDOLEAK ON FOLLOW-UP CT SCANS. REPORTEDLY, THE CAUSE WAS LOSS OF WALL APPOSITION DUE TO DISEASE PROGRESSION. ON (B)(6) 2026, THE PHYSICIAN REINTERVENED. A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS MAIN BODY WAS PLACED IN THE ABDOMINAL AORTA, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES WERE PLACED IN THE ILIAC ARTERIES. THE RIGHT INTERNAL ILIAC ARTERY WAS COVERED AND COILED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 25448607 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION AND A COOK DISSECTION STENT WAS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25318477 ↗
• InjuryMay 25, 2026No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2026, A PATIENT WAS TREATED FOR A THORACIC AORTIC DISSECTION USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) DEVICES. THE DEVICES WERE DEPLOYED SUCCESSFULLY. LATER ON (B)(6), AFTER THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE RIGHT LEG WEAKNESS. THIS IS LISTED AS A SPINAL CORD INJURY, AND A MINOR MOTOR DEFICIT OF THE LOWER EXTREMITIES. A LUMBAR DRAIN WAS USED TO TREAT. THIS EVENT IS LISTED AS RESOLVING ON MARCH 18, 2026.

  Patient problems: Paresis

  MAUDE report 25271814 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM IN THE DESCENDING THORACIC AORTA (FROM LEFT SUBCLAVIAN ARTERY TO CELIAC ARTERY) UTILIZING THREE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). THERE WERE NO ISSUES OR COMPLICATIONS REPORTED FOR THE INITIAL PROCEDURE. ON (B)(6), 2026, THE FIELD SALES ASSOCIATE WAS MADE AWARE THAT THE PATIENT WAS EXPERIENCING LIMITED MOVEMENT OF THE EXTREMITIES, HOWEVER, IT WAS NOT FULL PARALYSIS. REPORTEDLY THE CAUSE OF THE LIMITED MOVEMENT IS UNKNOWN AND IT IS UNKNOWN IF THE PATIENT HAS OR WILL RECEIVE ANY THERAPY FOR THE LIMITED MOVEMENT. THERE IS NO CLINICAL IMAGING AVAILABLE.

  Patient problems: Paresis

  MAUDE report 25243518 ↗
• InjuryMay 21, 2026Device Endoleak

  THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE TGR 23-02 CLINICAL STUDY: ON (B)(6) 2024, A PATIENT WAS TREATED FOR A THORACIC AORTIC DISSECTION AND TYPE 1A ENDOLEAK USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). ON (B)(6) 2026, A PATIENT WAS TREATED FOR A REINTERVENTION OF A TYPE 1A ENDOLEAK ON THE TBE, AS WELL AS A TYPE III ENDOLEAK BETWEEN THE TBE AND THE CTAG FROM JUNE 2024. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 25242288 ↗
• InjuryMay 15, 2026Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR TAMBE PROCEDURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC), GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WERE USED. REPORTEDLY, A CTAGAC WAS FIRST PLACED PROXIMAL TO THE CELIAC ARTERY TO ACHIEVE SEAL PRIOR TO DEPLOYMENT OF THE TAMBE DEVICE. FOLLOWING PLACEMENT OF THE TAMBE, AN INITIAL ANGIOGRAM DEMONSTRATED THAT THE CTAGAC APPEARED TO BE POSITIONED AT THE ORIGIN OF THE CELIAC ARTERY, WITH CONCERN FOR PARTIAL OCCLUSION. AS THE CELIAC PORTAL WAS ON THE SUPERIOR MESENTERIC ARTERY (SMA), A VBX WAS THEN PUT IN FROM THE CTAGAC AND COULD NO LONGER VISUALIZE THE CELIAC ARTERY. THE CELIAC ARTERY BECAME FULLY OCCLUDED WITH NO BLOOD FLOW. NO ADDITIONAL CLINICAL ISSUES RELATED TO THE OCCLUSION WERE REPORTED, AND THERE WERE NO PLANS TO REINTERVENE ON THE OCCLUDED CELIAC ARTERY. THE PHYSICIAN ATTRIBUTED THE CELIAC ARTERY OCCLUSION TO A COMBINATION OF THE CTAGAC AND VBX DEVICES.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25183509 ↗
• 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 ↗

Other W. L. Gore & Associates, Inc. products

• GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
• GORE DRYSEAL FLEX Introducer Sheath29 models · 1,009 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
• GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
• GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
• GORE DUALMESH Biomaterial13 models · 485 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports