GORE TAG Conformable Thoracic Stent Graft TGMR403415Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132661695), received between Nov 20, 2025 and May 15, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR TAMBE PROCEDURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC), GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WERE USED. REPORTEDLY, A CTAGAC WAS FIRST PLACED PROXIMAL TO THE CELIAC ARTERY TO ACHIEVE SEAL PRIOR TO DEPLOYMENT OF THE TAMBE DEVICE. FOLLOWING PLACEMENT OF THE TAMBE, AN INITIAL ANGIOGRAM DEMONSTRATED THAT THE CTAGAC APPEARED TO BE POSITIONED AT THE ORIGIN OF THE CELIAC ARTERY, WITH CONCERN FOR PARTIAL OCCLUSION. AS THE CELIAC PORTAL WAS ON THE SUPERIOR MESENTERIC ARTERY (SMA), A VBX WAS THEN PUT IN FROM THE CTAGAC AND COULD NO LONGER VISUALIZE THE CELIAC ARTERY. THE CELIAC ARTERY BECAME FULLY OCCLUDED WITH NO BLOOD FLOW. NO ADDITIONAL CLINICAL ISSUES RELATED TO THE OCCLUSION WERE REPORTED, AND THERE WERE NO PLANS TO REINTERVENE ON THE OCCLUDED CELIAC ARTERY. THE PHYSICIAN ATTRIBUTED THE CELIAC ARTERY OCCLUSION TO A COMBINATION OF THE CTAGAC AND VBX DEVICES.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25183509 ↗
• MalfunctionDec 12, 2025Break; Break

  THE FOLLOWING WAS SENT TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE TO TREAT A PENETRATING ATHEROSCLEROTIC ULCER UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, DURING THE PROCEDURE, A TAPERED CTAG NOSE CONE BROKE OFF INSIDE THE PATIENT'S BODY AND THE GRAFT LANDED 4CM DISTAL TO LEFT SUBCLAVIAN ARTERY AND THEN DISTALLY EXTENDED WITH ANOTHER CTAG. PATIENT HAD A PREVIOUS MEDTRONIC GRAFT IN THE INFRARENAL THAT HAD SLIPPED DOWN WITH VERY TORTUOUS ANATOMY AND CALCIFIED ILIAC ARTERY. THE CTAG TRACKED FINE AND DEPLOYED FINE. ONCE THE CATHETER WAS BROUGHT OUT, IT WAS NOTED THAT THE NOSE CONE WAS MISSING OF THE DELIVERY CATHETER AND UPON CHECKING, IT WAS SITTING JUST OFF THE INFRARENAL ON THE GUIDEWIRE. PHYSICIAN PUT A LUNDERQUIST WITH SNARE OVER IT AND TRACK WHERE IT WOULD OPEN UP ABOVE IT, BUT THE SNARE WOULD NOT GO PAST DUE TO TORTUOSITY OF THE INFRANRENAL AORTA, SO A 2ND GUIDEWIRE WAS PUT UP AND SNARE CATHETER THROUGH AND THE NOSE CONE WOULD THEN MOVE OVER THE LUNDERQUIST WITH SNARE THRU THE CTAG THAT THEY DEPLOYED AND SNARED THE TOP OF THE LUNDERQUIST WIRE AND PULL IT OUT THRU THE SHEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794393 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT PLANNED/STAGED ENDOVASCULAR TREATMENT OF A ZONE 4 DESCENDING THORACIC AORTIC DISSECTION AND WAS IMPLANTED WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICES (MOST PROXIMAL DEVICE TGMR403415/30110178. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THIS PATIENT UNDERWENT A PLANNED/STAGED ENDOVASCULAR TREATMENT OF A ZONE 4 DESCENDING THORACIC AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE, GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. (CAPTURED AS A NON-COMPLAINT ON TAMBE IN (B)(4) . ON (B)(6) 2025, THE PATIENT PRESENTED TO THE HOSPITAL WITH BACK PAIN AND CHEST PAIN. IT WAS REPORTED THAT A CT SCAN WAS PERFORMED AND THE PATIENT IS BEING WORKED UP FOR A POSSIBLE RE-INTERVENTION. A CAUSED WAS NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT¿S BLOOD PRESSURE WAS CONTROLLED AND THE ¿PAIN¿ HAS SUBSIDED. ON (B)(6) 2025, THE PATIENT WAS SCHEDULED FOR ENDOVASCULAR TREATMENT OF AN ACUTE/SUBACUTE TEVAR PROCEDURE FOR THE DISSECTION WITH GORE® TAG® THORACIC BRANCH ENDOPROSTH

  Patient problems: Vascular Dissection

  MAUDE report 23607092 ↗

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-0291-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0290-2021 · 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