GORE TAG Thoracic Branch Endoprosthesis TE4043ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132654338), received between Feb 16, 2024 and Apr 2, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS) USING A GORE®¿DRYSEAL FLEX INTRODUCER SHEATH AND A GORE® TRI-LOBE BALLOON CATHETER TO TREAT AN ASCENDING THORACIC DISSECTION. REPORTEDLY DURING THE PROCEDURE WHILE RETRACTING THE DELIVERY CATHETER OF THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER THE DEVICE MOVED DISTALLY AND PARTIALLY COVERED THE INNOMINATE ARTERY. THE PHYSICIAN IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN THE INNOMINATE ARTERY TO MAINTAIN PATENCY. THEN THE PHYSICIAN IMPLANTED A SECOND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE. POST PROCEDURE IMAGES REVEALED A TYPE B DISSECTION FROM IMPLANTED GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER EXTENDING DOWN INTO THE ILIAC ARTERY. THE PHYSICIAN IS NOT TREATING THE DISSECTION AT THIS TIME. THE EVENT IS ONGOING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 24770070 ↗
• InjuryJan 2, 2026Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A DISSECTION USING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. ON (B)(6) 2025, THE PATIENT WAS TREATED FOR A DISSECTION USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM, INCLUDING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. ON FOLLOW-UP CT, THE PHYSICIAN NOTED A PROXIMAL ENDOLEAK ON THE TBE DEVICE. ON (B)(6) 2025, A REINTERVENTION OCCURRED. A TBE EXTENDER WAS PLACED PROXIMALLY OF THE TBE DEVICE. AFTER DEPLOYMENT, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE CATHETER, BUT IT FELT LIKE IT WAS STUCK. THE PHYSICIAN PUSHED THE CATHETER FORWARD, AND WHEN THIS OCCURRED, THE DEPLOYED DEVICE ALSO PUSHED FORWARD, COVERING 80% OF THE INNOMINATE ARTERY. THE PHYSICIAN PERFORMED A LEFT SUBCLAVIAN - LEFT CAROTID BYPASS, AND THEN PLACED A VBX STENT IN THE INNOMINATE ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23946006 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AC) TO TREAT A THORACIC DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A REINTERVENTION TO TREAT A PROXIMAL TYPE I ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. THE FSA WAS NOT AT THIS PROCEDURE AND WAS NOT MADE AWARE OF A REINTERVENTION UNTIL (B)(6) 2024. CONSIGNMENT DEVICE WAS USED FOR THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 21112840 ↗
• InjuryApr 25, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2024, THE PATIENT WAS TREATED FOR A ZONE 2 THORACIC AORTIC DISSECTION. THE PHYSICIAN IMPLANTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT TAC084020A, TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES SIDE BRANCHES, (TSB081506A), AND A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER TE4043A. THE PATIENT TOLERATED THE PROCEDURE. ON A FOLLOW UP VISIT, IMAGING REVEALED A DISSECTION PROXIMAL TO THE TE4043A. THE PHYSICIAN BELIEVES THE DAMAGE IS TOO EXTENSIVE FOR ENDOVASCULAR REPAIR, AND IS PLANNING AN OPEN CONVERSION. IMAGES WERE RETURNED FOR EVALUATION.

  Patient problems: Vascular Dissection

  MAUDE report 19188321 ↗
• InjuryFeb 16, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2024, THE PATIENT WAS TREATED FOR A PAU. THE PHYSICIAN IMPLANTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT, A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH AND A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC BRANCH EXTENDER. WHEN THE EXTENDER WAS PLACED, IT ENDED UP PARTIALLY COVERING THE CAROTID ARTERY. BLOOD FLOW WAS RESTORED WITH A VBX, AND THE PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THE PLACEMENT ISSUE WAS BEING UNABLE TO SEE THE CAROTID DUE TO A PACEMAKER ON THE IMAGES.

  Patient problems: Reduced Blood Flow

  MAUDE report 18721350 ↗

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