GORE TAG Conformable Thoracic Stent Graft TGM282810Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132646937), received between Jan 21, 2022 and May 14, 2026 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Off-Label Use; Activation Failure

  ON (B)(6) 2026, THE PATIENT UNDERWENT A FROZEN ELEPHANT TRUNK (FET) PROCEDURE TO TREAT A DISSECTION UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). IT WAS REPORTED THAT DURING THE CTAG PORTION OF THE PROCEDURE, THE 3RD DEPLOYMENT HANDLE (LOCKWIRE HANDLE) WOULD NOT PULL OUT AFTER THE RED LOCKWIRE HANDLE WAS ROTATED 90 DEGREES COUNTERCLOCKWISE AND PULLED. THE PHYSICIAN WENT INTO THE BACKUP HATCH AND STILL COULD NOT PULL THE WIRE OUT. THE CAUSE OF THIS ISSUE IS UNKNOWN. SUBSEQUENTLY, THIS CTAG DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND ANOTHER CTAG DEVICE WAS SUCCESSFULLY DEPLOYED. PATIENT TOLERATED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171590 ↗
• InjuryApr 16, 2026Obstruction of Flow; Insufficient Device Problem Information

  ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A DEGENERATIVE THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. ALSO, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICES WERE USED IN THE PATIENT'S AORTA WITH THE TAMBE DEVICE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2025, PRE- TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC DISEASE WAS 65.3 MM. ON (B)(6), 2026, FOLLOW UP CTA SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC DISEASE WAS 66 MM. A PSEUDOANEURYSM OF THE LEFT SUBCLAVIAN ARTERY WAS NOTICED. THE PSEUDOANEURYSM WAS THROMBOSED. ON (B)(6), 2026, THE ANGIOGRAM WAS PERFORMED. TREATMENT SETTING: HOSPITAL OUTPATIENT. NO REINTERVENTION WAS DONE. HOWEVER, ACCORDING TO THE SITE, THE TREATMENT IS REQUIRED. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Pseudoaneurysm; Thrombosis/Thrombus

  MAUDE report 24903953 ↗
• InjuryMar 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT OF EITHER A PENETRATING ATHEROSCLEROTIC ULCER (PAU) OR INTRAMURAL HEMATOMA (IMH) IN THE DESCENDING THORACIC AORTA USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). IT WAS NOTED THAT THERE WAS INFLAMMATION AND POTENTIAL INFECTIOUS PROCESS AT THE TIME OF THE INDEX PROCEDURE, AND IT WAS UNCLEAR WHETHER THE PATHOLOGY WAS A PAU OR IMH. THERE WAS NO PRE-EXISTING DISSECTION PRESENT. ON (B)(6) 2025, THE PATIENT PRESENTED WITH PAIN. IMAGING WAS PERFORMED AND REVEALED WHAT THE PHYSICIAN CLASSIFIED AS A DISTAL STENT-GRAFT INDUCED NEW ENTRY TEAR. THERE WERE ALSO AIR BUBBLES NOTED AT THE DISTAL END OF THE IMPLANTED CTAG A/C DEVICE, SUGGESTING POTENTIAL GRAFT INFECTION. ON THE SAME DAY, TWO ADDITIONAL CTAG A/C DEVICES WERE IMPLANTED. THE PROCEDURE WAS COMPETED. THE PATIENT REPORTED BEING PAIN FREE POST-OP. NO TREATMENT HAS BEEN PERFORMED OR IS PLANNED FOR THE POTENTIAL INFECTION.

  Patient problems: Implant Pain; Unspecified Infection; Vascular Dissection

  MAUDE report 21602167 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A ZONE 4 THORACIC PSEUDOANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2025, FOLLOW UP IMAGES REVEALED A PENETRATING ATHEROSCLEROTIC ULCER PAU) DISTAL TO THE IMPLANTED DEVICE. THE PAU WAS NOT PRESENT DURING PROCEDURE ON (B)(6) 2024. THE PHYSICIAN IS NOT ATTRIBUTING THE NEW PAU TO THE IMPLANTED DEVICE. NO CALCIUM, PLAQUE OR THROMBUS PRESENT IN THE TREATMENT AREA. THE NEW PAU IS NOT ADJACENT TO THE IMPLANTED GORE DEVICE. REPORTEDLY ON (B)(6) 2025, THERE WAS A REINTERVENTION. THE PHYSICIAN IMPLANTED A (TGM282815 AND A TGMR313110) TO COVER THE PAU. THE PATIENT TOLERATED THE RE-INTERVENTION PROCEDURE. THE ROOT CAUSE OF NEW PAU IS NOT KNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 21553565 ↗
• MalfunctionApr 22, 2024Defective Device; Defective Device

  ON 27-MAR-2024, THE FSA WAS NOTIFIED BY A PHYSICIAN OF AN EVENT DURING A PROCEDURE ON (B)(6) 2024. WHILE TREATING A PATIENT FOR A THORACIC AORTIC ANEURYSM, THE PHYSICIAN IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGM282810. THE PHYSICIAN NOTICED THAT THE LOCK WIRE WAS NOT ATTACHED TO THE HANDLE. HE ATTEMPTED TO DEPLOY THE DEVICE, BUT THE DISTAL END WOULD NOT DEPLOY PROPERLY. IT WAS DECIDED TO REMOVE THE DEVICE AND COMPLETE THE PROCEDURE WITH ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES, AND THE PATIENT TOLERATED THE PROCEDURE. NO GORE FSA WAS PRESENT AT THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154155 ↗
• InjuryApr 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS EXPLANTED. PATIENT WAS BEING TREATED FOR BLUNT THORACIC INJURY. IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS DEPLOYING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, THE FIRST TWO HANDLES WERE PULLED AND DEVICE ENGAGED, HOWEVER WHILE THE LOCKWIRE WAS STILL ENGAGED, THE PHYSICIAN STARTED PULLING THE DELIVERY CATHETER DOWN AND OUT OF PATIENT. THIS CAUSED THE DEVICE TO MOVE DOWN AND "CRUMPLE ON ITSELF", BELOW THE CELIAC ARTERY AND SUPERIOR MESENTERIC ARTERY. THE DEPLOYMENT COULD NOT BE RESOLVED DURING ENDOVASCULAR PROCEDURE. THE PHYSICIAN CHOSE TO PERFORM AN OPEN REPAIR AND EXPLANT THE GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19035916 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A PSEUDOANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2024, THE PHYSICIAN PERFORMED A REINTERVENTION. THE SECONDARY CASE WAS COVERAGE OF CONTINUED ANEURYSMAL DEGENERATION PROXIMAL AND DISTAL TO THE IMPLANTED GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19033983 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A ZONE 4 DESCENDING THORACIC AORTIC PSEUDOANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT IMAGES (DATE AND MODALITY IS UNKNOWN) REVEALED A SMALL ARTERY TEAR JUST ABOVE WHERE THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS PLACED. POSSIBLE REINTERVENTION, DATE IS UNKNOWN CURRENTLY, THE EVENT IS ONGOING.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 18528148 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A ZONE 2 DESCENDING THORACIC AORTIC DISSECTION USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY THE PATIENT HAD AN AORTIC COARCTATION WITH A 180-DEGREE BEND JUST PAST THE LEFT SUBCLAVIAN ARTERY AND THEN WENT INTO TORTUOSITY (TWISTED IN OPPOSITE DIRECTION) JUST PAST THE AORTIC COARCTATION. WHEN ADVANCING THE LUNDERQUIST GUIDEWIRE, THE GUIDEWIRE STRAIGHTENED OUT THE THORACIC AREA HOWEVER WHEN THE FIRST GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS DEPLOYED IT DID NOT STAY STRAIGHT. THE DEVICE BUNCHED/SHORTENED (SHORTENED APPROXIMATELY 2-3 CM) AND ¿STOOD MORE STRAIGHT UP¿. THE PHYSICIAN CHOSE TO IMPLANT AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO SEE IF IT WOULD STRAIGHTEN OUT THE AREA, IT DID NOT. IT REACTED THE SAME AS THE FIRST DEPLOYED DEVICE IMPLANTED. THERE WAS A PLANNED LEFT CAROTID TO LEFT SUBCLAVIAN ARTERY BYPASS FOR THIS PROCEDURE. THE PHYSICIAN CHOSE TO PERFORM AN OPEN REPAIR. A BIFURCATED GRAFT WAS USED TO BYPASS FROM THE ASCENDING AORTA AND CONNECT THE GRA

  Patient problems: Vascular Dissection

  MAUDE report 18460357 ↗
• InjuryJan 5, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RUPTURED THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PHYSICIAN REPORTED THE PATIENT MAY POSSIBLY HAVE A POSSIBLE ENDOLEAK. POST REVIEW OF THE PATIENT¿S COMPUTED TOMOGRAPHY (CT), NO OBVIOUS ENDOLEAK WAS SEEN. ON (B)(6) 2023, THE PATIENT UNDERWENT FOLLOW-UP CT WAS PERFORMED AND THE PHYSICIAN REPORTS NO OBVIOUS TYPE I ENDOLEAK(S) WERE SEEN HOWEVER HE CHOSE TO RE-INTERVENE. THE PHYSICIAN REPORTED THAT DURING THE PROCEDURE WHEN PLACING A WIRE UP THE RIGHT ILIAC ARTERY, HE NOTICED THAT THERE WAS A PROBLEM WITH THE WIRE GOING INTO THE AORTA. AN ANGIOGRAM WAS PERFORMED AND DETERMINED A LARGE ANEURYSM IN THE RIGHT COMMON ILIAC ARTERY (RCIA), CLOSE TO THE AORTIC BIFURCATION. THE CTAG AC WAS EXTENDED WITH TWO ADDITIONAL CTAG AC¿S BOTH PROXIMALLY AND DISTALLY AND THE ABDOMINAL AORTA AND RCIAA WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 18457485 ↗
• MalfunctionMar 29, 2023Device Handling Problem; Device Handling Problem

  ON (B)(6) 2023, THIS PATIENT UNDERWENT OPEN/ENDOVASCULAR TREATMENT FOR A DISSECTION. IT WAS REPORTED THAT A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ADVANCED ANTEGRADE THROUGH THE CHEST WITHIN A FROZEN ELEPHANT TRUNK. IT WAS REPORTED THAT THE FIRST STAGE OF DEPLOYMENT ¿MISFIRED¿. IT WAS REPORTED THAT THE PHYSICIAN THEN PULLED THE PRIMARY DEPLOYMENT HANDLE TO GET THE DEVICE TO 50% DEPLOYMENT BUT THE PHYSICIAN DID NOT FEEL THE DEVICE DEPLOYED CORRECTLY OR FULLY AND THE INNER CURVE APPEARED PULLED DOWN. IT IS UNKNOWN IF THE DEVICE WAS ADVANCED OVER A GUIDEWIRE OR NOT. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURERS DEVICE. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICE IS BEING RETURNED TO GORE FOR EVALUATION, THE RESULTS WILL BE PROVIDED WITH THE SUBMISSION OF A SUPPLEMENTAL MEDWATCH.

  Patient problems: Vascular Dissection

  MAUDE report 16637613 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DISSECTION AND WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT RE-INTERVENTION FOR DISTAL EXTENSION OF THE DISSECTION AND COVERAGE WAS EXTENDED WITH THE IMPLANT OF A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC). THE CAUSE OF THE EXTENSION OF THE DISSECTION WAS NOT KNOWN. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 15407583 ↗
• InjuryAug 10, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2022, THE PATIENT WAS TREATED EMERGENTLY FOR A TRANSECTED THORACIC AORTA. IN ORDER TO REPAIR THE TRANSECTION, THE PHYSICIAN ELECTED TO IMPLANT A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, IN A LOCATION THAT INCLUDED THE INTENTIONAL COVERAGE OF THE LEFT SUBCLAVIAN ARTERY. IT WAS RECOGNIZED THAT THIS COULD COMPROMISE THE PATIENT'S RIGHT ARM AND CEREBROVASCULAR STATUS, SO THE PATIENT WAS MONITORED. THE FOLLOWING DAY, THE FOLLOWUP PHYSICIAN PERFORMED A REVISION TO PERFUSE THE LEFT SUBCLAVIAN. HE FENESTRATED THE CTAG FROM THE LEFT ARM AND USED A PERIPHERAL COVERED STENT TO PERFUSE THE LSA. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198614 ↗
• MalfunctionJan 21, 2022Difficult to Fold, Unfold or Collapse; Device Handling Problem; Difficult to Fold, Unfold or Collapse; Device Handling Problem

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A PENETRATING AORTIC ULCER AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) WAS IMPLANTED. IT WAS REPORTED THAT THE PHYSICIAN LOOSENED AND TURNED THE GRAY SECONDARY DEPLOYMENT HANDLE AND PULLED BACK TO DEPLOY THE DEVICE TO IT¿S FULL DIAMETER BUT THE DEPLOYMENT LINE GOT STUCK AFTER HAVING ONLY BEEN PULLED OUT ABOUT AN INCH. THE PHYSICIAN THEN PULLED BACK HARDER AND THE DEPLOYMENT LINE BROKE. THE LOCKWIRE AND ANGULATION ASSEMBLIES WERE REMOVED WITH THE DEVICE DELIVERY SYSTEM. A BALLOON CATHETER WAS THEN ADVANCED TO BALLOON THE DEVICE TO FULL EXPANSION. THE PROCEDURE WAS CONCLUDED WITH FULL EXPANSION OF THE DEVICE AND SUCCESSFUL PLACEMENT WHERE INTENDED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ulcer

  MAUDE report 13318141 ↗

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