GORE TAG Conformable Thoracic Stent Graft TGMR373115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132661688), received between Feb 6, 2026 and Feb 9, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED ON THE NEXT DAY, THE PATIENT LOST BILATERAL LOWER EXTREMITY MOTOR FUNCTION. A SPINAL DRAIN WAS PLACED PRE-OPERATIVELY AS A PRECAUTION, AND WAS FUNCTIONING CORRECTLY. IT WAS ALSO REPORTED THERE WERE NO ISSUES OBSERVED DURING THE PROCEDURE WITH ANY OF THE GORE DEVICES. THE PHYSICIAN ATTRIBUTES THIS PARALYSIS DUE TO TOTAL COVERAGE OF THE THORACIC AND ABDOMINAL AORTA AT SAME STAGE, AND DOES NOT BELIEVE THE GORE DEVICES CAUSED THE PARALYSIS. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 24293506 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 0 (ASCENDING AORTA) WITH BCA (BRACHIOCEPHALIC ARTERY) TEVAR TREATMENT FOR ANEURYSM FROM A DISSECTION. THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS DEVICE AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TSB121706A, TGMR373115, TSB121706A, TAC124515A, TE4546A). THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION TO TREAT CONTINUED ANEURYSMAL DEGENERATION OF THE ANEURYSM DUE TO INFECTION OF THE PATIENT¿S AORTA AND OF THE ANEURYSM. THE SIDE BRANCH DEVICE WAS EXTENDED PROXIMALLY AND THE TBE AORTIC COMPONENT WAS EXTENDED WITH A CTAG. THE PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THE INFECTION IS NOT KNOWN. THE PHYSICIAN REPORTS THAT AT THE PATIENT¿S 30-DAY FOLLOW-UP COMPUTED TOMOGRAPHY (CT) ALL LOOKED GOOD HEALTHY AND NO DEVICE ISSUES OR CONCERNS NOTED. THE PATIENT HAD OBSERVED DEVICE ISSUES. THE PATIENT THEN STATED THEY HAD A FOLLOW-UP CT AT ANOTHER HOSPITAL IN (B)(6) AND THE AORTA HAD GOTTEN PROGRESSIVELY WORSE. THE PHYSICIAN DOES NOT KNOW IF THERE WAS UNDETECTED INFECTION AT THE TIME OF THE INDEX PRO

  Patient problems: Post Operative Wound Infection

  MAUDE report 24283600 ↗

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-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0291-2021 · 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-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm
• Z-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm