GORE TAG Conformable Thoracic Stent Graft TGMR312610Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132646760), received between Dec 5, 2019 and Jan 9, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

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

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM AND A 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. THE PROCEDURE REQUIRED THAT A CTAG TAPERED STENT GRAFT BE PLACED TO LAND THE TAMBE COMPONENT INSIDE OF. DURING THE CASE, IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO WIRE CANNULATE THE CELIAC ARTERY DUE TO THE TORTUOSITY OF THE PATIENT¿S ANATOMY. AFTER AN EXTENSIVE AMOUNT OF TIME, IT WAS DECIDED TO INSTANT WIRE THE SMA, RIGHT RENAL, AND LEFT RENAL. THE CELIAC PORTAL WAS EXTENDED WITH A VBX AND A 14 MM AMPLATZ PLUG WAS PLACED INSIDE OF THE VBX STENT. ADDITIONALLY, IT WAS BELIEVED DURING THE CASE, THAT POSSIBLY DUE TO POOR IMAGING AND VISUALIZATION OF THE CELIAC ARTERY THAT THE CTAG MAY HAVE BEEN COVERING THE ORIGIN. THE PATIENT TOLERATED THE PROCEDURE AND WAS R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027557 ↗
• InjuryMay 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED EMERGENTLY FOR A TRANSECTION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG). THE NEXT MORNING, IT WAS REPORTED THAT THE PATIENT HAD A STROKE. AS OF (B)(6) 2025, THE PHYSICIAN IS STILL WORKING TO GET THE PATIENT HEALTHY.

  Patient problems: Stroke/CVA

  MAUDE report 21985747 ↗
• InjuryFeb 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE UTILIZING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR313115 & TGMR313120) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS TO TREAT A PROXIMAL TYPE 1 ENDOLEAK WITH GROWING ANEURYSM (SIZE UNKNOWN). REPORTEDLY, PHYSICIAN EXTENDED PROXIMALLY WITH A TGMR313115 FIRST OVER TO THE LEFT COMMON CAROTID ARTERY. THE DEVICE CAME BACK A LITTLE BIT THEN PHYSICIAN ADDED A TGMR313120 WHICH SEALED THE ENDOLEAK PERFECTLY, AFTER WHICH, PHYSICIAN HAD TO PUT A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS INTO THE LEFT COMMON CAROTID ARTERY AS A PRECAUTION AS THE DEVICE GOT A LITTLE TOO FAR ACROSS THE OSTIUM. THERE WAS NO ISSUES WITH BLOOD FLOW DURING THE PROCEDURE AND BLOOD FLOW REMAINED EFFICIENT AS THE PROCEDURE ENDED SUCCESSFULLY WITH PATIENT BEING DISCHARGED THE SAME DAY. PHYSICIAN SUSPECTS CAUSE OF THE ENDOLEAK AND ANEURYSM GROWTH IS DUE TO THE PATIENT'S VEHICULAR TRANSACTION ACCIDENT.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21406431 ↗
• InjuryJun 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, (DATE UNKNOWN), THE PATIENT HAD A REPEAT CTA DONE THAT SHOWED THE ASCENDING MEASURED 5 TO 5.2CM, AND THE DESCENDING MEASURED 5.6CM AND THE ABDOMINAL ANEURYSM MEASURED 6.8CM WITH MURAL THROMBUS. PATIENT WAS THEN REFERRED TO (B)(6)HOSPITAL BY DR.(B)(6) AT WELLSPAN. ON (B)(6), 2021, THE PATIENT HAD AN ENDOVASCULAR REPAIR OF DESCENDING THORACIC AORTA AND LEFT CAROTID TO LEFT AXILLARY BYPASS BY DR. (B)(6) AND DR. (B)(6). ON (B)(6) 2021, THE PATIENT HAD FBEVAR SECOND STAGE PROCEDURE. STAGE II OF AN EXTENT II ENDOVASCULAR THORACOABDOMINAL ANEURYSM REPAIR USING 4-VESSEL FENESTRATION CUSTOM MADE GRAFT BY MODIFICATION OF A COOK TX2 42 X 34 X 160 MM THORACIC GRAFT. FENESTRATIONS WERE CREATED FOR THE CELIAC TRUNK, SUPERIOR MESENTERIC ARTERY, AND BOTH RENAL ARTERIES. CELIAC TRUNK AND SUPERIOR MESENTERIC ARTERY FENESTRATIONS WERE REINFORCED WITH NITINOL RING WITH AN 8 X 8 MM FENESTRATION. RENAL ARTERY FENESTRATIONS WERE MADE WITH NITINOL RING AND 6 X 6 MM FENESTRATIONS. BOTH RENAL ARTERIES WERE STENTED USING UNKNOWN SIZE OF (?? X 22 MM) ICAST STENTS. SUPERIOR MESENTERIC ARTERY AND CELIAC TRUNK WERE STENTED USING AN 8 X 29 VBX STENT. PROXIMAL EX

  Patient problems: Clinical Endoleak

  MAUDE report 17189984 ↗
• InjuryJul 13, 2022Migration; Migration

  ON (B)(6) 2022 THE PATIENT UNDERWENT EMERGENT REPAIR OF A BLUNT TRAUMATIC AORTIC INJURY USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). IT WAS REPORTED THAT THE PHYSICIAN INTENTIONALLY COVERED THE PATIENT'S LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS SUCCESSFULLY ADVANCED UP TO THE PATIENT'S LEFT COMMON CAROTID ARTERY. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH DEVICE PLACEMENT UPON CLOSE OF THE PROCEDURE. IT WAS ALSO NOTED THAT THE DEVICE WAS NOT BALLOONED AFTER DEPLOYMENT DUE TO THE TRAUMATIC NATURE OF THE INJURY. ON (B)(6) 2022 THE GORE REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD EXPERIENCED A STROKE. IT WAS REPORTED THAT FOLLOW-UP IMAGING REVEALED THAT THE CTAG A/C DEVICE HAD MIGRATED PROXIMALLY. THE DEVICE WAS REPORTEDLY COVERING MOST OR ALL OF THE PATIENT'S LEFT COMMON CAROTID ARTERY AND THE STROKE WAS ATTRIBUTED TO THE ARTERY COVERAGE. THE PATIENT REPORTEDLY SURVIVED THE STROKE. IT WAS REPORTED THAT SOME STROKE INTERVENTION WAS PERFORMED BUT DETAILS ARE UNAVAILABLE. OTHER OUTCOMES ARE REPORTEDLY UNKNOWN.

  Patient problems: Ischemia Stroke; Obstruction/Occlusion

  MAUDE report 15009334 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE (B)(6) CLINICAL STUDY. ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC TYPE B AORTIC DISSECTION, ZONE 2. GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED IN THE DISTAL SIDE. INTRAOPERATIVE AORTOGRAPHY SHOWED NO SPECIFIC ADVERSE EVENT. ON (B)(6) 2021, CONTRAST-ENHANCED CT SHOWED THAT THE FALSE LUMEN PROXIMAL TO THE STENT GRAFT WAS COMPLETELY THROMBOSED, BUT THERE WAS RESIDUAL BLOOD FLOW FROM THE END OF THE STENT GRAFT TO THE ABDOMINAL AORTA. AT THIS POINT, IT WAS UNCLEAR WHETHER THE LUMINAL BLOOD FLOW WAS DUE TO RE-ENTRY FLOW OR NEW ENTRY TEAR. ON (B)(6) 2022, NON-ENHANCED CT SHOWED AN ENLARGED FALSE-LUMEN DIAMETER IN THE SAME AREA. SO IT WAS DIAGNOSED THAT THE FALSE LUMEN BLOOD FLOW WAS DUE TO NEW ENTRY TEAR AND DECIDED ADDITIONAL TREATMENT. TREATMENT DETAILS IS NOT REPORTED. REPORTEDLY THIS EVENT ORIGINATED FROM THE DISTAL EDGE OF THE STENT GRAFT, IT IS CONSIDERED TO BE CAUSED BY CTAGAC AND ITS OVERSIZING.

  Patient problems: Vascular Dissection

  MAUDE report 13556926 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (TGMR312610/20930283) TO TREAT A CONTAINED RUPTURED DISTAL THORACIC AORTIC ANEURYSM (FIELD SALES ASSOCIATE REPORTED THAT THE CONTAINED RUPTURED ANEURYSM GAVE THE APPEARANCE OF A PSEUDOANEURYSM WITH A PENETRATING AORTIC ULCER). THE PHYSICIAN HAD PLANNED TO COVER THE CELIAC ARTERY DUE TO THE ORIGIN OF THE CONTAINED RUPTURED ANEURYSM. REPORTEDLY, THE PHYSICIAN HAD TO UTILIZE A COONS TAPER DILATOR TO EXPAND THE RIGHT EXTERNAL ILIAC ARTERY. AN AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0) 20FR (LOT/SERIAL NUMBER IS NOT AVAILABLE) WAS INSERTED INTO THE RIGHT EXTERNAL ILIAC ARTERY AND WOULD NOT ADVANCE BEYOND APPROXIMATELY 5CM. THE PHYSICIAN CHOSE TO CREATE AN ENDOVASCULAR CONDUIT USING A GORE® VIABAHN® ENDOPROSTHESIS (VBH100502A/21178878). THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL WAS DEPLOYED PER INSTRUCTIONS FOR USE (IFU) WITH NO ISSUES. IT WAS REPORTED THAT FOLLOWING DEPLOYMENT TO FULL DIAMETER, THE LOCK WIRE AND ANGULATION FIBERS WERE REMOVED SUCCESSFULLY. REMOVAL OF THE CATHETER MET RESISTANCE AND IT SEEMED AS THOUGH A PROXIMAL UNCOVERED STENT

  Patient problems: Aneurysm

  MAUDE report 9418961 ↗

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-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
• Z-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm