GORE TAG Conformable Thoracic Stent Graft TGM454510Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132646982), received between Oct 2, 2020 and Sep 17, 2025 — classified as 2 deaths, 4 injuries, 2 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathSep 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN AORTIC DISSECTION UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). IT WAS REPORTED DURING THE PROCEDURE; THE PHYSICIAN INFORMED THE FSA THAT A CTAG DEVICE FROM CONSIGNMENT HAD BEEN IMPLANTED. SUBSEQUENTLY, THEY REQUESTED AN ADDITIONAL CTAG DEVICE. AS THE FSA WAS EN ROUTE TO ANOTHER CASE, HE DELIVERED THE REQUESTED DEVICE AND DEPARTED. THEY PHYSICIAN LATER INFORMED THE FSA THAT THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE FSA WAS INFORMED THAT THE PATIENT HAD EXPERIENCED A MAJOR STROKE. FOLLOWING THE DECISION TO WITHDRAW CARE, THE PATIENT PASSED AWAY ON EITHER (B)(6) 2025. ADDITIONAL DETAILS INDICATED THAT THE PATIENT HAD A SIGNIFICANT AMOUNT OF THROMBUS IN THE CAROTID ARTERY, WHICH WAS SUSPECTED TO HAVE BROKEN OFF, CAUSING THE STROKE. THE EXACT LOCATION WITHIN THE CAROTID ARTERY WHERE THE THROMBUS ORIGINATED IS UNKNOWN. THE PHYSICIAN DOES NOT BELIEVE THE EVENT WAS DEVICE-RELATED.

  Patient problems: Stroke/CVA

  MAUDE report 23074151 ↗
• InjuryJun 9, 2025Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM PROXIMAL TO THE BRACHIOCEPHALIC TRUNK, DISTAL TO THE SINO TUBULAR JUNCTION (ZONE 0) WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. PRE- TREATMENT MAXIMUM THORACIC AORTIC ANEURYSM DIAMETER WAS 61.4MM. FROM (B)(6) 2022 TO (B)(6) 2025, THE MAXIMUM AORTIC DIAMETER INCREASED IN SIZE FROM 65MM TO 72.3MM. ACCORDING TO THE SITE, THE PATIENT HAS DISTAL ANEURYSMAL DISEASE (TYPE IV)- DISTAL THORACIC AORTA AND VISCERAL SEGMENT ANEURYSM. THE EVENT IS ONGOING. ACCORDING TO THE SITE, THIS PROBLEM IS UNRELATED TO THE DEVICE OR PROCEDURE. THE PATIENT IS GOING TO BE TREATED FOR TYPE IV SEGMENT ON (B)(6) 2025.

  Patient problems: Aneurysm expansion

  MAUDE report 22172758 ↗
• MalfunctionOct 17, 2024Difficult to Remove; Difficult to Remove

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR AN ANEURYSM IN ZONE 4 OF THE DESCENDING THORACIC AORTA USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL (CTAG) AND GORE® DRYSEAL FLEX INTRODUCER SHEATHS (DSF). THE PHYSICIAN BEGAN BY INSERTING A 24FR SHEATH INTO THE PATIENT THROUGH THE RIGHT FEMORAL ARTERY. ALTHOUGH THERE WAS SUPPOSED TO BE PLENTY OF ROOM IN THE ACCESS VESSEL, THE PHYSICIAN HAD DIFFICULTY INSERTING THE DSF. HOWEVER, HE WAS ABLE TO GET THE DSF IN PLACE. THE PHYSICIAN THEN INSERTED THE 1ST CTAG DEVICE. THE PHYSICIAN NOTED DIFFICULTY IN ADVANCING THE DEVICE THROUGH THE SHEATH, BUT EVENTUALLY GOT THE DEVICE INTO PLACE. THE FIRST TWO STAGES OF THE DEVICE DEPLOYED SUCCESSFULLY. WHEN ATTEMPTING TO REMOVE THE ANGULATION FIBERS, THE FIBERS WOULD NOT COME OUT. AS THE PHYSICIAN PULLED ON THE HANDLE, THE WIRE BROKE. THE PHYSICIAN OPENED THE BACK-UP DEPLOYMENT HATCH, AND PULLED ON THE WIRE. IT REQUIRED A GREAT DEAL OF FORCE, BUT EVENTUALLY THE WIRE WAS ABLE TO BE REMOVED. HOWEVER, DURING REMOVAL, THE DEVICE WAS PULLED DISTALLY. ORIGINALLY, THE PHYSICIAN HAD PLANNED TO TREAT WITH ONE CTAG DEVICE, BUT BECAUSE OFF THE MOVEMENT OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478150 ↗
• InjuryDec 6, 2023Device Handling Problem; Device Handling Problem

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC). THE CTAG-AC WAS THE MOST PROXIMAL DEVICE AND WAS DEPLOYED JUST DISTAL TO THE LOWEST RENAL ARTERY WITH THE EXCLUDER TRUNK HAVING BEEN DEPLOYED WITHIN THE CTAG-AC DUE TO THE SIZE OF THE PATIENT AORTA AND THE SIZE OF THE ANEURYSM (7CM). POST DEPLOYMENT OF ALL DEVICES AND ANGIOPLASTY OF ALL THE DEVICES A SMALL PROXIMAL TYPE I ENDOLEAK WAS NOTED. A SECOND BALLOON INFLATION WITH A GORE® TRI-LOBE BALLOON CATHETER (BCL2645/26440564) ENSUED WITH THE TRI-LOBE BALLOON CATHETER UPON WHICH THE PROXIMAL AORTA WAS NOTICED TO HAVE RUPTURE . THE PATIENT WAS CONVERTED TO OPEN WHEREIN ALL THE DEVICES WERE EXPLANTED AND A DACRON GRAFT WAS SEWN INTO THE AORTA. THE PATIENT TOLERATED THE PROCEDURE. THE RUPTURE IS BELIEVED TO HAVE BEEN DUE TO OVERINFLATION OF THE BALLOON DURING ANGIOPLASTY.

  Patient problems: Rupture

  MAUDE report 18273539 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 3 THORACIC AORTIC ANEURYSM AT AN OUTSIDE FACILITY. AN ANEURYSM DEVELOPED PROXIMAL TO THE TREATMENT AREA IN THE PATIENT'S AORTIC ARCH. ON (B)(6) 2023, A ZONE 0 ENDOVASCULAR TREATMENT OF THE AORTIC ARCH ANEURYSM WAS PERFORMED USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE POST-OPERATIVELY ON THE SAME DAY. THE CURRENT PATIENT STATUS REMAINS UNAVAILABLE.

  Patient problems: Stroke/CVA

  MAUDE report 17592812 ↗
• MalfunctionJun 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A ZONE 2 DISSECTION. IT WAS REPORTED THAT WHILE THE PHYSICIAN ATTEMPTED TO DEPLOY THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM THE LAST 2CM OF THE CONSTRAINING SLEEVE REMAINED CLOSED. THE PHYSICIAN WENT IN WITH A SHEATH AND BALLOON THROUGH THE LEFT SUBCLAVIAN ARTERY AND BALLOONED THE UNDEPLOYED END OF DEVICE. THE DEVICE WAS IMPLANTED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 17113936 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AT MOUNT SANAI HOSPITAL USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM IN AN OFF LABEL MANNER IN THE PATIENT'S ABDOMINAL AORTA. ON OR AROUND (B)(6) 2022, THE PATIENT PRESENTED TO NORTH SHORE UNIVERSITY HOSPITAL. A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED WITH ENLARGEMENT OF THE AORTIC NECK. ANEURYSM ENLARGEMENT WAS NOT REPORTED. IT WAS ALSO REPORTED THAT THERE WAS A HIGH SUSPICION OF GRAFT INFECTION AS THE TISSUE SURROUNDING THE GRAFT WAS INFLAMED. THERE WAS NO REPORTED PREEXISTING INFECTION, AND THE PHYSICIAN SUSPECTED THAT THE GRAFT MAY HAVE CAUSED/CONTRIBUTED TO THE INFECTION AS THE INDEX PROCEDURE WAS RECENT. THE PHYSICIAN SUGGESTED THAT THE DEVICES SHOULD BE EXPLANTED. HOWEVER, THERE IS NO PLANNED DATE OF EXPLANT AS THE PATIENT MAY RETURN TO MOUNT SANAI HOSPITAL FOR THE EXPLANT PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 15332384 ↗
• DeathOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE WHEREBY A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL WAS IMPLANTED IN THE THORACIC AORTA, PROXIMALLY TO A PREVIOUSLY IMPLANTED COOK® CUSTOM MADE DEVICE, TO TREAT A SUSPECTED ENDOLEAK OF UNKNOWN ORIGIN. IT IS UNKNOWN FOR WHAT PATHOLOGY THE COOK® CUSTOM MADE DEVICE WAS IMPLANTED. MEASUREMENTS OF THE THORACIC AORTA WERE NOT PROVIDED. AFTER DEPLOYING THE GORE® TAG® DEVICE, THE PHYSICIAN PERFORMED BALLOONING (BALLOON MANUFACTURER UNKNOWN). UPON BALLOONING, THE THORACIC AORTA RUPTURED. TWO ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL DEVICES WERE IMPLANTED PROXIMALLY. HOWEVER, THE PATIENT DID NOT RECOVER AND EXPIRED.

  Patient problems: Death

  MAUDE report 10621644 ↗

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-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