GORE TAG Thoracic Branch Endoprosthesis TE3742ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132654321), received between Sep 20, 2023 and Jun 4, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Malposition of Device” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P210032); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). ON (B)(6) 2026, THE PATIENT UNDERWENT A 2ND STAGED ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). ON (B)(6) 2026, THE PATIENT RETURNED FOR A REINTERVENTION BASED ON CT FINDINGS THAT SUGGESTED A TYPE IA ENDOLEAK AT THE PROXIMAL TBE GRAFT. THE INTERVAL CT SCAN BETWEEN THE TBE AND TAMBE PROCEDURES HAD SHOWN NO EVIDENCE OF ENDOLEAK; HOWEVER, THE POST TAMBE CT SCAN RAISED CONCERN FOR A PROXIMAL TYPE IA LEAK. DURING THE PROCEDURE, AN ARTERIOGRAM WAS PERFORMED TO IDENTIFY THE SOURCE OF THE SUSPECTED TYPE IA ENDOLEAK. NO TYPE IA ENDOLEAK WAS VISUALIZED. INSTEAD, A TYPE III ENDOLEAK DUE TO COMPONENT DISCONNECTION WAS IDENTIFIED BETWEEN THE TBE MAIN GRAFT AND A TBE EXTENDER. A SECOND EXTENDER WAS PLACED, BUT THIS DID NOT RESOLVE THE LEAK. THE PHYSICIAN THEN ELECTED TO USE A 9 × 7.5 CM VIABAHN TO EXTEND THE TBE SIDE BRANCH BACK INTO THE AORTA, FOLLOWED BY PLACEMENT OF A 37 × 10 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIV

  Patient problems: Clinical Endoleak

  MAUDE report 25391565 ↗
• InjuryMar 9, 2026Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AA PENETRATING AORTIC ULCER (PAU) AND INTRAMURAL HEMATOMA (IMH) UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC EXTENDER). REPORTEDLY, THE AORTIC EXTENDER JUMPED FORWARD DURING DEPLOYMENT WITH APPROXIMATELY 8-10MM AND COVERED APPROXIMATELY 90% OF THE LEFT COMMON CAROTID ARTERY (LCCA) INADVERTENTLY. PHYSICIAN PERFORMED A LEFT SUBCLAVIAN ARTERY (LSA) -LCCA BYPASS TO REVASCULARIZE THE LEFT COMMON CAROTID ARTERY WITH BLOOD FLOW RESTORED TO NORMAL AND THE PATIENT IS DOING WELL AND HAS BEEN DISCHARGED WITH NO ISSUES POST-OP. THE CAUSE OF THE AORTIC EXTENDER MOVING FORWARD DURING DEPLOYMENT IS UNKNOWN AND THERE WERE NO ANATOMICAL CHALLENGES WITH TORTUOSITY OR CALCIUM.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24551644 ↗
• InjuryNov 28, 2023Malposition of Device; Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT A BRANCHED THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE TO TREAT AN ARCH PSEUDOANEURYSM IN ZONE 2 LEFT COMMON CAROTID ARTERY (LCCA) UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). REPORTEDLY, DURING DEPLOYMENT GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (STENT GRAFT THORACIC BRANCH AORTIC EXTENDER) THERE WAS AN ISSUE THAT THE PHYSICIAN WAS AWARE OF PRIOR TO PROCEDURE THAT THE PROXIMAL END OF THE PLANNED TBE DEVICE (TAC083415A) WAS NOT LIKELY TO EXTEND BEYOND THE PAU AS THE PAU STARTED IN ZONE 2 ((IE. PROXIMAL SEAL ZONE DID NOT MEET IFU FOR TBE DEVICE). IN ANTICIPATION OF THIS, THE PHYSICIAN PLANNED TO EXTEND PROXIMAL TO THE LEFT COMMON CAROTID ARTERY (LCCA) WITH THE TE3742A (AORTIC EXTENDER) IN ORDER TO SEAL BEYOND THE PAU. DURING DEPLOYMENT OF TE3742A, THERE WAS 4-5MM OF PROXIMAL MIGRATION OF THE DEVICE RESULTING IN PARTIAL COVERAGE OF THE LCCA. TO ENSURE ADEQUATE PERFUSION (BLOOD FLOW) OF LCCA, PHYSICIAN PLACED A 8 X 29MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN THE LCCA AND POST-DILATED TO 10MM PUSHING PROXIMAL EDGE OF THE TE3742A GRAFT BACK. PATIENT IS DOING WELL POST-OP

  Patient problems: Obstruction/Occlusion

  MAUDE report 18221256 ↗
• InjurySep 20, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, A CT SCAN WAS PERFORMED WHICH REVEALED THE SAME TYPE 1 ENDOLEAK, WITH NO CHANGES OR SIGNS OF IMPROVEMENT. POST-OP IMAGING SHOWED THAT THE AORTIC EXTENDER WAS ~3.5CM PROXIMAL TO THE TBE AORTIC COMPONENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17786143 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P210032. One submission often covers many models, so check the product and lot details in each record.

• Z-2672-2026 · May 19, 2026 · Open, Classified
  GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB08