GORE TAG Conformable Thoracic Stent Graft TGM282815Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00733132646944), received between Aug 5, 2019 and Jun 9, 2026 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Endoleak” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Inadequacy of Device Shape and/or Size; Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM PLACED AS THE DISTAL. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PHYSICIAN NOTICED A TYPE 1B ENDOLEAK ON FOLLOW-UP CT SCANS. REPORTEDLY, THE CAUSE WAS LOSS OF WALL APPOSITION DUE TO DISEASE PROGRESSION. ON (B)(6) 2026, THE PHYSICIAN REINTERVENED. A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS MAIN BODY WAS PLACED IN THE ABDOMINAL AORTA, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES WERE PLACED IN THE ILIAC ARTERIES. THE RIGHT INTERNAL ILIAC ARTERY WAS COVERED AND COILED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 25448607 ↗
• InjuryMay 25, 2026No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2026, A PATIENT WAS TREATED FOR A THORACIC AORTIC DISSECTION USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) DEVICES. THE DEVICES WERE DEPLOYED SUCCESSFULLY. LATER ON (B)(6), AFTER THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE RIGHT LEG WEAKNESS. THIS IS LISTED AS A SPINAL CORD INJURY, AND A MINOR MOTOR DEFICIT OF THE LOWER EXTREMITIES. A LUMBAR DRAIN WAS USED TO TREAT. THIS EVENT IS LISTED AS RESOLVING ON MARCH 18, 2026.

  Patient problems: Paresis

  MAUDE report 25271814 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM IN THE DESCENDING THORACIC AORTA (FROM LEFT SUBCLAVIAN ARTERY TO CELIAC ARTERY) UTILIZING THREE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). THERE WERE NO ISSUES OR COMPLICATIONS REPORTED FOR THE INITIAL PROCEDURE. ON (B)(6), 2026, THE FIELD SALES ASSOCIATE WAS MADE AWARE THAT THE PATIENT WAS EXPERIENCING LIMITED MOVEMENT OF THE EXTREMITIES, HOWEVER, IT WAS NOT FULL PARALYSIS. REPORTEDLY THE CAUSE OF THE LIMITED MOVEMENT IS UNKNOWN AND IT IS UNKNOWN IF THE PATIENT HAS OR WILL RECEIVE ANY THERAPY FOR THE LIMITED MOVEMENT. THERE IS NO CLINICAL IMAGING AVAILABLE.

  Patient problems: Paresis

  MAUDE report 25243518 ↗
• InjuryFeb 17, 2026Obstruction of Flow

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C) DEVICES WERE USED IN THE PATIENT'S AORTA WITH THE TAMBE DEVICE. DURING THE INDEX PROCEDURE, A RIGHT AND LEFT ACCESSORY RENAL ARTERIES COIL EMBOLIZATION PROCEDURE WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, SPINAL CORD ISCHEMIA WAS NOTED. TREATMENT LISTED IS A LUMBAR DRAIN AND BLOOD PRESSURE AUGMENTATION.

  Patient problems: Ischemia

  MAUDE report 24373031 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG-AC) SYSTEM DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION FOR A INDETERMINATE ENDOLEAK AND SUSPECTED PSEUDOANEURYSM AND AN UNKNOWN ISSUE WITH THE VISCERAL SECTION OF THE DISTAL DEVICE. THE PATIENT WAS OPENED UP AND THE DISTAL PORTION OF GRAFT WAS CUT OUT AND REMOVED. A DACRON VASCULAR GRAFT WAS SEWN INTO THE REMAINING PORTION THE CTAG-AC AND SUTURED AROUND OUR DEVICE AND THEN SUTURED IN THE CELIAC TRUNK ARTERY. FOUR ADDITIONAL CTAG-AC DEVICES WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. CODED 1800-E:-IMPLANTABLE DEVICE EVENTS POST DEPLOYMENT - OTHER/UNKNOWN TO CAPTURE " UNKNOWN ISSUE WITH THE VISCERAL SECTION OF THE DISTAL DEVICE".

  Patient problems: Clinical Endoleak

  MAUDE report 23348460 ↗
• MalfunctionJun 19, 2025Failure to Deliver; Failure to Deliver

  ON (B)(6) 2025, DURING AN ENDOVASCULAR PROCEDURE INVOLVING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, THE DEVICE WAS ADVANCED TO THE INTENDED DEPLOYMENT SITE. THE PHYSICIAN INITIATED THE FIRST STAGE OF DEPLOYMENT BY TURNING THE PRIMARY DEPLOYMENT HANDLE 90° COUNTER-CLOCKWISE AND PULLING IT TO DEPLOY THE DEVICE TO ITS INTERMEDIATE DIAMETER. HOWEVER, THE DEVICE REMAINED FULLY CONSTRAINED, AND NO DEPLOYMENT OCCURRED. ALTHOUGH THE PRIMARY DEPLOYMENT LINE DETACHED ALONG WITH THE HANDLE, THE STENT GRAFT DID NOT EXPAND TO ITS INTERMEDIATE DIAMETER. THE PHYSICIAN SUBSEQUENTLY WITHDREW THE DEVICE FROM THE PATIENT. A SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT FURTHER INCIDENT. IT WAS NOTED THAT THE BACKUP HATCH HAD BEEN OPENED, BUT NO PRIMARY DEPLOYMENT LINE WAS PRESENT. THE PATIENT TOLERATED THE PROCEDURE WELL. THE INITIAL DEVICE WAS RETAINED AND WILL BE RETURNED TO GORE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289556 ↗
• InjuryMar 21, 2025Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Device Endoleak; Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC). REPORTEDLY, A CTAG WAS DEPLOYED AT THE LSA, APPROXIMATELY 1-2CM PROXIMAL TO EXISTING COOK THORACIC DEVICE. IT WAS REPORTED THAT THE DEPLOYMENT STEPS WENT WITHOUT ISSUES, HOWEVER, IT WAS UNABLE TO REMOVE AN ANGULATION FIBER. EXTREMELY RESISTANCE EXPERIENCED WHEN THE PHYSICIAN PULL ON THE LINE#4. WITH FORCE IT WAS REMOVED, HOWEVER THIS CAUSED THE GRAFT TO ANGULATE AND BEND IN ON ITSELF. LOST ALL INFERIOR AORTIC SEAL ZONE. DIFFICULTY REMOVING CATHETER AS GRAFT WAS BENT IN. FORCED TO DRAW BACK LUNDERQUIST TO HELP GET WIRE INTO CENTER OF AORTA AND THEN WAS ABLE TO REMOVE CATHETER. GRAFT WAS THEN BALLOONED WITH A 32 CODA AT KINKED AREA WHICH HELPED REDUCE THE BEND, HOWEVER PROXIMAL SEAL ZONE WAS LOST. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE GORE PRODUCT SPECIALIST HAD A MEETING WITH THE IMPLANTING PHYSICIAN, AND THE PHYSICIAN INFORMED THAT ALTHOUGH THE INTRAOPERATIVE ANGIOGRAM DID NOT SHOW AN ENDOLEAK, THE FOLLOW-UP CT DID REVEAL AN ENDOLEAK. THEY ARE CONSIDERING REINTERVENTION TO ADDRESS THE ENDOL

  Patient problems: Clinical Endoleak

  MAUDE report 21660921 ↗
• InjuryFeb 12, 2025Material Deformation; Material Deformation

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ASCENDING REPAIR A ZONE 4 DESCENDING DISSECTION. IN ADDITION, PHYSICIAN ALSO IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAGAC) SYSTEM (IMPLANTED RETROGRADE). ON AN UNKNOWN DATE DURING A FOLLOW-UP CT, IT WAS OBSERVED THE CTAGAC GRAFT WAS IN-FOLDED AT THE DISTAL END OF THE GRAFT, CLOSEST TO THE LSC. ON (B)(6) 2025, PATIENT UNDERWENT A REINTERVENTION. PHYSICIAN EXTENDED THE PREVIOUS GRAFT WITH A NEW 28X15 TAG, (29580512) TO THE LCC AFTER PERFORMING A LCC-LSC BYPASS. PHYSICIAN WAS ABLE TO EXPAND THE PREVIOUS GRAFT IN-FOLD BY PLACING THE ADDITIONAL CTAGAC AND BALLOONING. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS IN-FOLDING ISSUE. NO FURTHER PATIENT OR IMAGES INFORMATION ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367245 ↗
• MalfunctionJul 27, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ON (B)(6) 2021, THE PATIENT WAS TREATED FOR A DISSECTION OF THE ASCENDING AORTA. AN OPEN PROCEDURE WAS PERFORMED, AND THE PHYSICIAN PERFORMED A FROZEN ELEPHANT TRUNK PROCEDURE. HE DEPLOYED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, BUT WHEN HE TRIED TO USE THE RED KNOB TO COMPLETE THE THIRD STEP OF THE DEPLOYMENT, HE FOUND IT DIFFICULT TO MOVE, AND ENDED UP BREAKING THE DEPLOYMENT LINE. THE PHYSICIAN DID NOT REMEMBER HOW TO CUT THE LINE USING THE ESCAPE HATCH, SO ENDED UP REMOVING THE DEVICE. A SECOND DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICE WAS DISCARDED AT THE FACILITY, AS THE PATIENT WAS HIV POSITIVE, AND THE HOSPITAL DID NOT WISH TO RELEASE THE CONTAMINATED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12226390 ↗
• InjuryFeb 12, 2021Difficult or Delayed Activation; Malposition of Device; Difficult or Delayed Activation; Malposition of Device

  ON (B)(6) 2020 THE PATIENT UNDERWENT OPEN REPAIR OF THE THORACIC AORTA USING A FROZEN ELEPHANT TRUNK TECHNIQUE WITH ANTEGRADE RELEASE OF A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). IT WAS REPORTED THAT, UPON ATTEMPTED REMOVAL OF THE GRAY ANGULATION ASSEMBLY HANDLE, THE ANGULATION FIBERS BECAME STUCK AND WOULD NOT RELEASE FROM THE CATHETER. REPORTEDLY THE LEADING OLIVE TIP OF THE CATHETER WAS BEING PULLED AS THE HANDLE WAS PULLED, AND IT APPEARED THAT THE WIRE WAS TUGGING ON THE DELIVERY CATHETER. IT WAS NOTED THAT ALL OTHER PREVIOUS DEPLOYMENTS WERE SMOOTH AND WITHOUT ISSUE. IT WAS REPORTED THAT THE DEPLOYMENT LINE ACCESS HATCH WAS OPENED, AND DEPLOYMENT WAS SUCCESSFULLY COMPLETED FROM THE HANDLE. REPORTEDLY, DURING THE FINAL DEPLOYMENT STEPS, THE CTAG A/C DEVICE MOVED DISTALLY FROM THE INTENDED LANDING ZONE. IT WAS REPORTED THAT, AS THE DEVICE HAD MOVED DISTALLY FROM THE INTENDED LANDING ZONE AND WAS DEPLOYED IN THE INCORRECT LOCATION, THE SURGEON REMOVED THE DEVICE. A VALIANT NAVION¿ GRAFT WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11325743 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM TO TREAT A THORACIC DISSECTION WITH IDIOPATHIC MYOCARDIAL HYPERTROPHY. IT WAS REPORTED THAT AFTER THE PHYSICIAN DEPLOYED THE THORACIC ENDOPROSTHESIS AT THE LEVEL OF THE CAROTID, THE OUTER SLEEVE COVERED THE CAROTID ARTERY. THE METAL STENT DID NOT CROSS THE OSTIUM. THE SLEEVE PARTIALLY OCCLUDED THE CAROTID. THE PHYSICIAN CHOSE TO USE A BARE METAL STENT IN THE CAROTID ARTERY SO THAT BLOOD FLOW COULD REMAIN OPEN. THE PATIENT TOLERATED THE PROCEDURE. THERE WAS NO ANATOMY ANOMALIES. THE PHYSICIAN DID NOT USE FORCE OR HAVE ANY ISSUES DURING IMPLANT. IT IS UNKNOWN WHY THIS OCCURRED.

  Patient problems: Aortic Dissection

  MAUDE report 10049451 ↗
• InjuryAug 5, 2019Positioning Failure; Positioning Failure

  ON (B)(6), 2019, THE PATIENT WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL TO TREAT A THORACIC AORTIC ANEURYSM.

  Patient problems: Aneurysm

  MAUDE report 8862403 ↗

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