GORE TAG Conformable Thoracic Stent Graft TGM342815Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132661664), received between Nov 14, 2025 and Feb 24, 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 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG) WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED TO TREAT THE ABDOMINAL AND THORACIC AORTA. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED TO TREAT THE AORTIC MAIN VISCERAL VESSELS. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT DEVELOPED PARAPLEGIA AND UNDERWENT PLACEMENT OF A SPINAL DRAIN. THE PHYSICIAN BELIEVES POOR MANAGEMENT OF THE PATIENT¿S HYPOTENSION AND A MAP IN THE 60¿S FOR A FEW HOURS PRECEDING THE PARAPLEGIA WERE CONTRIBUTORY FACTORS AND NOT DEVICE RELATED BUT A NEUROLOGICAL DEFICIT.

  Patient problems: Paraplegia

  MAUDE report 24434740 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A PENETRATING ATHEROSCLEROTIC ULCER (PAU) IN THE THORACIC AORTA. REPORTEDLY THERE WAS C-ARM OBLIQUITY, AND THE PHYSICIAN WAS HAVING ISSUES WITH ARTICULATING THE DEGREE THAT WAS NEEDED FOR THIS PROCEDURE. AFTER THE DEVICE WAS IMPLANTED, THERE WAS 75-80% PARTIAL COVERAGE OF THE LEFT SUBCLAVIAN ARTERY (LSA). TWENTY-FOUR HOURS POST PROCEDURE THE PATIENT DEVELOPED LEFT ARM NUMBNESS AND PARAPARESIS. THERE WERE ALSO ISSUES WITH THE A-LINE THAT WAS IN THE LEFT WRIST. ON (B)(6) 2025, THE PHYSICIAN PERFORMED A REINTERVENTION AND IMPLANTED A BARE-METAL STENT IN THE LSA. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Reduced Blood Flow

  MAUDE report 23563000 ↗

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