GORE EXCLUDER Thoracoabdominal Branch EndoprosthesisRecalls & reported problems across all models

We found 2 models of GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 92 adverse event reports in the FDA's MAUDE database, received between Jul 2, 2024 and Sep 30, 2026 — classified as 17 deaths, 66 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 EXCLUDER Thoracoabdominal Branch Endoprosthesis problems

GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis models

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

• GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis ATAA43720160A

  Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
  10 deaths67 reports
• GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis ATAA43120160A

  Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
  7 deaths25 reports

Recent GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis adverse event reports

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

• MalfunctionSep 30, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951348 ↗
• InjurySep 21, 2026Obstruction of Flow

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50842351 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Ischemia

  MAUDE report 50797009 ↗
• InjurySep 16, 2026Device Endoleak

  Patient problems: Clinical Endoleak

  MAUDE report 50793846 ↗
• InjurySep 16, 2026Patient-Device Incompatibility

  Patient problems: Clinical Endoleak

  MAUDE report 50787630 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  The patient referenced in this event file is enrolled in the AAA 24-01 TAMBE Post Approval Study. The following information was reported from the iMedidata Clinical Database:On (b)(6) 2026, a patient underwent treatment for a thoracoabominal aortic aneurysm utilizing a GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) system of components. On (b)(6) 2026, the patient was suffering for lower extremity weakness. MRI showed no evidence of spinal cord ischemia. Treatment was a spinal drain, and vasopressor support. The weakness was improving upon discharge on (b)(6) to inpatient rehab.

  Patient problems: Paresis

  MAUDE report 50022044 ↗
• 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 25449422 ↗
• InjuryJun 9, 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 25448305 ↗
• DeathMay 7, 2026No Apparent Adverse Event

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM GORE® EXCLUDER® AAA ENDOPROSTHESIS IMPLANTED IN THE ABDOMINAL AND THORACIC AORTA ALONG WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED TO TREAT THE AORTIC MAIN VISCERAL VESSELS. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT EXPIRED; THE PHYSICIAN REPORTS THE CAUSE OF DEATH WAS DEAD BOWL/BOWEL ISCHEMIA. THE PHYSICIAN DOES NOT ALLEGE ANY DEFICIENCY OF THE GORE DEVICES AND STATES THEY ALL PERFORMED AS INTENDED AND THE PROCEDURE HAD BEEN CONCLUDED WITH GOOD TECHNICAL RESULTS. FOLLOW-UP COMPUTED TOMOGRAPHY HAD SHOWN ALL DEVICES TO BE PATENT, WITH NO ENDOLEAK OR INDICATION OF DISSECTION.

  Patient problems: Ischemia

  MAUDE report 25117339 ↗
• DeathMay 7, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT THREE OF THE FOUR VISCERAL VESSELS WERE DEPLOYED, WHEN THE PHYSICIAN WAS AT THE FINAL STAGE OF DEPLOYING THE TAMBE DEVICE, THEY NOTICED THE PROXIMAL END OF THE DEVICE HAD PULSATILE MOVEMENT. IVIS WAS DONE AND DETERMINED THERE WAS A RETROGRADE DISSECTION. THE DISSECTION STARTED FROM THE TOP OF THE TAMBE GRAFT (LANDED APPROXIMATELY 65 CM ABOVE CELIAC ARTERY) AND WENT INTO THE ASCENDING THORACIC AORTA. THERE WAS NO PRE-EXISTING DISSECTION. THE PATIENT WAS TAKEN TO A DIFFERENT HOSPITAL, AND AN OPEN REPAIR WAS DONE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, A FOLLOW UP CT REVEALED THE FALSE LUMEN WAS STILL PRESSURIZED. A REINTERVENTION OCCURRED, AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED. THE LEFT SUBCLAVIAN ARTERY WAS COVERED AND PLANNED; THIS WAS A STAGED SURGERY. THERE WAS A PLAN TO PERFORM A BYPASS SURGERY OF THE LEFT SUBCLAVIAN ARTERY ON A DIFFERENT DATE. THE PATIENT TOLERATED THE PRO

  Patient problems: Vascular Dissection

  MAUDE report 25112463 ↗
• InjuryMay 6, 2026Insufficient Device Problem Information

  THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE AAA 24-01 TAMBE POST APPROVAL STUDY. THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA CLINICAL DATABASE: ON (B)(6) 2026, A PATIENT WAS TREATED FOR A DEGENERATIVE THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM OF COMPONENTS. REPORTEDLY, DURING THE PROCEDURE THE PATIENT SUFFERED AN ACUTE KIDNEY INJURY. THE CAUSE IS LISTED AS PROCEDURE RELATED, AND NOT RELATED TO A GORE DEVICE. THE PATIENT STARTED DIALYSIS (B)(6), AND THAT IS LISTED AS ONGOING. IT SHOULD BE NOTED THAT PRIOR TO THE PROCEDURE, THE RIGHT RENAL ARTERY WAS STENOSED, AND THE CASE PLAN SHOWED THAT THEY DID NOT PLAN TO PLACE A STENT IN IT.

  Patient problems: Renal Impairment

  MAUDE report 25094067 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6), 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6), 2026, THERE WAS A REINTERVENTION FOR ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). THE CAUSE OF THE ENLARGEMENT IS UNKNOWN, COULD NOT BE CONFIRMED FROM IMAGES (POSSIBLY A PROXIMAL TYPE I ENDOLEAK OR A TYPE II ENDOLEAK). THE PHYSICIAN IMPLANTED A DEVICE PROXIMALLY OF THE TAMBE DEVICE AND EXTENDED THE STENT (VBX) IN THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE. REPORTEDLY, THE PATIENT HAD EXTREMELY TORTUOUS ANATOMY.

  Patient problems: Clinical Endoleak

  MAUDE report 25037955 ↗
• InjuryApr 28, 2026Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED FROM THE AAA 24-01 TAMBE POST APPROVAL STUDY AND INFORMATION WAS OBTAINED FROM THE IMEDIDATA CLINICAL DATABASE: ON (B)(6) 2026, A PATIENT WAS TREATED USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). ON (B)(6) 2026, THE PATIENT WAS LISTED AS HAVING AN ACUTE KIDNEY INJURY. THE EVENT IS LISTED AS PROCEDURE RELATED, AND THE EVENT IS ONGOING, BUT NO TREATMENT IS LISTED. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED HOME. THE RENAL ARTERIES WERE PATENT PRIOR TO THE PROCEDURE. IT IS UNKNOWN IF ANY DEVICES WERE PLACED IN THE RENAL ARTERIES. ON THE RISK ASSESSMENT FORM, PRIOR TO PROCEDURE RENAL STATUS IS GIVEN A SCORE OF 2, INDICATING PATIENT CREATININE LEVELS ARE ELEVATED, BETWEEN 2.5 AND 5.9 MG/DL. AT DISCHARGE, 5 DAYS POST-OP THE CREATININE LEVEL WAS 1.25 MG/DL.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 25018103 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT WAS TREATED USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM. DURING THE PROCEDURE, ILIAC ACCESS WAS INADEQUATE (8MM) FOR THE 22 FR DSF, AND THE PHYSICIAN STRUGGLED TO ADVANCE THE SHEATH, BUT WAS EVENTUALLY ABLE TO GAIN ACCESS. THE REST OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2026, THE PATIENT WAS NO LONGER ABLE TO MOVE THEIR LEGS. THEIR PULSE WAS LOW, AND THEIR LEGS WERE COLD. A THROMBECTOMY WAS PERFORMED ON BOTH LEGS, DISTAL TO THE GORE GRAFTS. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL FOR A POST-OP SPINAL DRAIN - HOWEVER, NO FLUID WAS ABLE TO BE DRAINED, SO THE PROCEDURE WAS UNSUCCESSFUL. ON AN UNKNOWN DATE, A CT SCAN WAS TAKEN, SHOWING A TYPE B DISSECTION WITH ENTRY TEAR AT THE LEFT SUBCLAVIAN, AND EXTENDING DOWN THE DESCENDING THORACIC TO THE PROXIMAL END OF THE TAMBE. NO CHEST CT HAD BEEN TAKEN PRIOR TO THE PROCEDURE, AND THE PHYSICIAN COULD NOT RULE OUT THAT IT WAS PRESENT PRIOR TO THE PROCEDURE. HOWEVER, THE DISSECTION APPEARED TO BE NEW. THE PHYSICIAN DECIDED TO MEDICALLY MANAGE THE DISSECTION. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED FROM TO A REHAB FACIL

  Patient problems: Ischemia

  MAUDE report 24925622 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF A CONTAINED RUPTURED ANEURYSM AT THE ABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE PROCEDURE WAS A TECHNICAL SUCCESS, AND THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, A SPINAL DRAIN WAS PLACED JUST PRIOR TO THE TAMBE PROCEDURE AND THERE WERE DIFFICULTIES WITH THE PLACEMENT. IT WAS REPORTED POST PROCEDURE MARCH 10, 2026, THAT THE PATIENT HAD A SUBDURAL HEMATOMA OF THE SPINAL CORD SECONDARY TO THE SPINAL DRAIN WITH SPINAL CORD ISCHEMIA. THIS WAS NOTED POST-OP WHEN ANESTHESIA OPENED THE DRAIN TO INITIATE DRAINING. ON MARCH 10, 2026, THE PATIENT PRESENTED WITH BILATERAL LOWER EXTREMITY WEAKNESS UPON ARRIVAL AT THE ICU AT 2300. THE PATIENT EXHIBITED SIGNS OF STROKE AND UPON EXTUBATION THE PATIENT WAS APHASIC AT 0000. ON (B)(6) 2026, SUBDURAL HEMATOMA OF SPINE CONFIRMED BY MRI. ISCHEMIC STROKE WAS NOTED ALSO. ON (B)(6) 2026, LATER IN THE DAY, THE PATIENT HAD BEGUN TO SHOW SIGNS OF RECOVERY. IMPROVEMENT OF UPPER EXTREMITY WEAKNESS AND BEGAN TO SPEAK SOME WORDS. ON (B)(6) 2026, THE PATIENT SUFFERED FROM ASPIRATION OF FLUID AND SUBSEQUENT INTUBATION. AT TH

  Patient problems: Hemorrhagic Stroke

  MAUDE report 24900540 ↗

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