GORE TAG Conformable Thoracic Stent Graft TGMR313115Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132646784), received between Apr 2, 2020 and Jun 15, 2026 — classified as 2 deaths, 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED AFTER THE IMPLANT PROCEDURE; THE PATIENT EXPERIENCED WEAKNESS IN THE LEGS AND THAT PROGRESSED INTO LOWER EXTREMITY PARALYSIS. THERE WAS NO INTERVENTION, THE EVENT IS ONGOING. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY TO TREAT THE NEUROLOGICAL DEFICIT. REPORTEDLY A SPINAL DRAIN WAS PLACED PRE-PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 25506746 ↗
• DeathJul 14, 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) 2025, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, IT IS UNKNOWN, IF DURING OR AFTER PROCEDURE BUT PATIENT PASSED AWAY THE SAME DAY. FIELD SALES ASSOCIATE WAS NOT PRESENT FOR THIS PROCEDURE. ON (B)(6) 2025, PER MEDICAL DEVICE TRACKING SYSTEM THAT A DEVICE CARD WAS PROVIDED BY THE HOSPITAL WITH DEVICE INFORMATION AND NOTE OF PATIENT BEING DECEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493127 ↗
• MalfunctionJun 16, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM IN THE DESCENDING THORACIC AORTA, UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG) DEVICE. DURING THE PROCEDURE THE DEVICE WAS INSERTED. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE 1ST STAGE, THE GRAFT WOULD NOT DEPLOY. AS THE PHYSICIAN PULLED HARDER, THE TIP OF CATHETER STARTED TO BEND DOWN. AT THIS POINT, SINCE THE DEVICE WAS NOT DEPLOYED, THE PHYSICIAN DECIDED TO REMOVE THE DEVICE, AND WAS ABLE TO DO SO EASILY. THE BACK UP HATCH WAS NOT USED, AS DEVICE WAS STILL CONSTRAINED. ANOTHER CTAG DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214169 ↗
• MalfunctionDec 5, 2024Fracture; Fracture

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DESCENDING ANEURYSM, UTILIZING CTAGAC DEVICE. DURING DEVICE PREP, THE THERE WAS DIFFICULTY IN REMOVING THE PROTECTIVE PACKAGING SLEEVE. DURING THE PROCEDURE, AFTER THE STENT GRAFT WAS DEPLOYED, UPON REMOVING THE CTAGAC DEVICE, THE PHYSICIAN HEARD A POP NOISE. THE NOSE CONE FROM THE DELIVERY CATHETER BROKE OFF. THE NOSE CONE CAME OFF WHILE IN THE SHEATH. PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE SHEATH, GET THE NOSE CONE OUT, AND ADVANCED THE SHEATH AGAIN TO FINISH THE PROCEDURE WITHOUT FURTHER ISSUES. THE CAUSE REMAINS UNKNOWN. NO PATIENT ADVERSE EVENTS OCCURRED. PATIENT TOLERATED THE PROCEDURE. DELIVERY CATHETER WAS DISCARDED. NO FURTHER PATIENT INFORMATION OR IMAGES ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853235 ↗
• MalfunctionJul 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A THORACIC AORTA ZONE 3 INTRAMURAL HEMATOMA AND ENLARGING PENETRATING AORTIC ULCER (PAU). REPORTEDLY A COOK LUNDERQUIST 035¿ DOUBLE CURVE WIRE WAS PLACED IN A STANDARD MANNER AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF2033/LOT SERIAL NUMBER IS UNK) WAS INTRODUCED TO THE INFRARENAL AORTA. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR313115) WAS INTRODUCED THROUGH THE SHEATH WITH SOME DIFFICULTY. THE PHYSICIAN LATER COMMENTED THAT IT WAS "TIGHT" IN THE SHEATH. THE TGMR313115 DEVICE WAS ADVANCED TO THE AORTIC ARCH HOWEVER THE PROXIMAL ALIGNMENT MARKER WAS POSITIONED TO THE LESSER CURVE OF THE AORTIC ARCH. THE SUB OPTIMAL ORIENTATION WAS NOTED, AND THE DEVICE WAS ADVANCE THE TO THE ASCENDING AORTA AND THEN RETRACTED TO THE DESCENDING AORTA TWO TIMES IN AN EFFORT THE REORIENT THE ALIGNMENT MARKER TO THE GREATER CURVE. THE ALIGNMENT MARKER DID ASSUME THE GREATER CURVE IN THE DESCENDING AORTA HOWEVER IT REASSUMED THE LESSER CURVE AT THE DESIRED DEPLOYMENT LOCATION. THE PHYSICIAN ELECTED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726411 ↗
• InjuryJul 8, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A PAU IN THE DESCENDING THORACIC AORTA, UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). DURING THE PROCEDURE, THE GRAFT HAD MOVED DISTALLY (15-20CM), DUE TO PHYSICIAN INADVERTENTLY NOT RELEASING STAGE 3 (LOCKWIRE RELEASE) OF THE CTAGAC. THERE WAS A TEMPORARY COVERAGE OF THE CELIAC, SMA AND BOTH RENALS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY PULLING THE GRAFT DOWN FURTHER INTO THE ABDOMINAL AORTA AND ADDITIONAL STENTS (PALMAZ STENTS) WERE PLACED INSIDE. PATENCY OF ALL OF THOSE VESSELS WERE RESTORED AND CONFIRMED VIA ANGIOGRAM. PATIENT TOLERATED THE PROCEDURE. NO IMAGES OR FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19688641 ↗
• DeathMar 17, 2024Off-Label Use; Off-Label Use

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A SYMPTOMATIC ASCENDING THORACIC AORTIC DISSECTION USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND A GORE® VIABAHN® ENDOPROSTHESIS WAS IMPLANTED IN THE BRACHIOCEPHALIC ARTERY. THE PATIENT WAS ADMITTED TO THE HOSPITAL IN AN UNSTABLE CONDITION. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY ON (B)(6) 2024, THE PATIENT WAS UNSTABLE AND ADMITTED EMERGENTLY FOR A PERICARDIAL EFFUSION AND A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN PERFORMED A REINTERVENTION AND PLANNED AN OPEN REPAIR AND DEBRANCHING. A PROCEDURE FOR THE PERICARDIAL EFFUSION WAS DONE PRIOR TO THE OPEN REPAIR. THE PATIENT EXPIRED LATER THAT DAY, ON (B)(6) 2024. THE PHYSICIAN ATTRIBUTED THE PATIENT¿S DEATH TO COMPLICATIONS FROM THE PERICARDIAL EFFUSION.

  Patient problems: Clinical Endoleak

  MAUDE report 18919160 ↗
• InjurySep 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2023, THE PATIENT UNDERWENT A BRANCHED ENDOGRAFT PROCEDURE STARTING FROM THE LEFT SUBCLAVIAN ARTERY (ZONE 2) TO THE LEVEL OF 10TH THORACIC VERTEBRAE (T10) WITH THE DISTAL END OF GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM APPROXIMATELY 6CM ABOVE THE CELIAC ARTERY TO TREAT A TYPE B THORACIC DISSECTION UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (BRANCH AORTIC COMPONENT), GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (SIDE BRANCH) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC). REPORTEDLY, THE PROCEDURE WENT WELL WITH ALL DEVICES BEING IMPLANTED WITH NO ISSUES AND PATIENT TOLERATED THE PROCEDURE. DUE TO THE PROCEDURE GOING FROM THE LEFT SUBCLAVIAN ARTERY TO THE THORACIC VERTEBRAE (T10), FIELD SALES ASSOCIATE (FSA) RECOMMENDED A SPINAL DRAIN BEFORE THE PROCEDURE BUT PHYSICIAN DECIDED IT WAS NOT NECESSARY. LATER THAT NIGHT, AFTER 10 HOURS FROM THE PROCEDURE, WHEN PATIENT WAS IN THE ICU, PATIENT DEVELOPED NUMBNESS IN FEET FROM THE UMBILICUS TO BILATERAL FEET (DEVELOPED BILATERAL PARALYSIS). PATIENT NOTIFIED THE NURSE, AT WHICH POINT THE DOCTOR STOPPED THE HEPARIN AND THE

  Patient problems: Paraplegia; Vascular Dissection

  MAUDE report 17736687 ↗
• MalfunctionJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED: IT WAS REPORTED THAT ON (B)(6) 2022, THE PHYSICIAN WAS TREATING THE PATIENT FOR A TYPE A TRANSVERSE ARCH ACUTE DISSECTION APPROXIMATELY THREE MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT. THE PHYSICIAN HAD MID STERNUM SURGICAL EXPOSURE AND WAS ATTEMPTING TO DEPLOY A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INTO THE TRANSVERSE AORTIC ARCH RETROGRADE AND WITHOUT A SHEATH OR GUIDEWIRE. THE DEVICE DEPLOYED AND WAS IN PLACE BUT THERE WAS A STRING STILL ATTACHED AT THE END OF THE GRAFT AND TO THE DELIVERY CATHETER (IT IS UNKNOWN WHICH STRING REMAINED ATTACHED; THE FIELD SALES ASSOCIATE WAS NOT AT THE PROCEDURE). THE PHYSICIAN HAD TO USE SURGICAL SCISSORS TO DETACH THE STRING FROM THE DEVICE. THE DELIVERY CATHETER WAS DESTROYED AT THE HOSPITAL AFTER USE. AFTER DEPLOYMENT THE PHYSICIAN NOTICED A BROKEN PIECE OF PLASTIC INSIDE THE DELIVERY HANDLE. THE PATIENT TOLERATED THE PROCEDURE WITH NO ADVERSE EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 16198992 ↗
• MalfunctionJun 17, 2020Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ACUTE THORACIC AORTIC TYPE A AND B DISSECTION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ENDOPROSTHESIS. IT WAS REPORTED THAT LINE 3 (WHICH IS THE RED HANDLE) BROKE WHEN TRYING TO DEPLOY THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ENDOPROSTHESIS, WHICH DISENGAGES THE CATHETER FROM THE DEVICE. AFTER DOING THAT THE PHYSICIAN ISOLATED THE LINE AT THE BACK END OF THE CATHETER WHERE THE HANDLE WAS SUPPOSED TO BE AND TRIED TO PULL THE LINE WITH A HEMOSTAT, BUT COULD NOT. THE PHYSICIAN THEN OPENED UP THE BACKUP HATCH AND AGAIN ISOLATED LINE 3 AND TRIED TO DEPLOY WITH A HEMOSTAT, BUT COULD NOT DEPLOY, AND THE LINE 3 WIRE BROKE. AS A FINAL ATTEMPT, THE CATHETER WAS CUT IN HALF, DOWN CLOSER TO THE END, AND THE PHYSICIAN WAS ABLE TO FIND LINE 3 WITH A HEMOSTAT AND HE PULLED IT OUT EASILY. THE CATHETER DISENGAGED FROM THE STENT WITHOUT DISLODGING THE STENT OR CAUSING ANY PROBLEMS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 10165735 ↗
• MalfunctionApr 2, 2020Separation Failure; Separation Failure

  ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A DISSECTION. IT WAS REPORTED THAT PRIOR TO THE DEVICES BEING IMPLANTED, THERE WAS AN OPEN SURGICAL REPAIR OF THE TOTAL AORTIC ROOT AND AN AORTIC ARCH REPLACEMENT. ONCE THE ELEPHANT TRUNK WAS IN PLACE, THE PHYSICIAN WANTED TO EXTEND DISTALLY INTO THE DESCENDING THORACIC AORTA WITH A GORE ENDOPROSTHESIS. THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED WITH NO ISSUE. WHEN IMPLANTING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, THE PRIMARY SLEEVE DEPLOYED WITHOUT INCIDENCE. UPON ATTEMPTING TO DEPLOY THE SECONDARY SLEEVE (TRAILING TO LEADING END) WOULD NOT RELEASE. THE PHYSICIAN STATED THAT THE ¿RED HANDLE SNAPPED AND THE DELIVERY CATHETER WOULD NOT RELEASE FROM THE DEVICE¿. THE PHYSICIAN HAD ACCESS DUE TO THE OPEN REPAIR, AND WAS ABLE TO CUT THE LOCKWIRE AND ANGULATION FIBERS TO RELEASE THE DELIVERY CATHETER FROM THE DEVICE AND REMOVE FROM THE PATIENT. THE DEVICE WAS ADVANCED OVER A WIRE VIA DIRECT PLACEMENT FROM THE ARCH (OPEN REPAIR OF ASCENDING) AKA FROZEN

  Patient problems: No Known Impact Or Consequence To Patient; Vascular Dissection

  MAUDE report 9919054 ↗

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