GORE TAG Thoracic Branch Endoprosthesis TAC124015ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132654239), received between Jul 17, 2023 and Mar 24, 2026 — classified as 2 deaths, 3 injuries, 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (P210032); 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.

• InjuryMar 24, 2026Device Endoleak

  ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT CHRONIC DISSECTION WITH FALSE LUMEN ANEURYSMAL GROWTH IN THE THORACIC AORTA UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (B)(6) IN ZONE 2 AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (B)(6) EXTENDED DISTALLY. THE PATIENT UNDERWENT MULTIPLE FOLLOW-UP CT SCANS THROUGH 2024 WHICH SHOWED GOOD RESULTS. THE PATIENT WAS DUE FOR THE NEXT FOLLOW-UP IN 2026. ON (B)(6) 2026, THE PATIENT WAS SHOWING SYMPTOMATIC SIGNS OF A RUPTURE, WITH MEDIASTINAL SHIFT, CHEST/BACK PAIN, AND HYPOTENSION. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE. THE PHYSICIAN BELIEVES AT SOME POINT BETWEEN 2024 AND (B)(6) 2026, THE SEPTUM TORE OPEN IN THE EXISTING DISSECTION (DISSECTION FROM INITIAL PROCEDURE) AT THE DISTAL END OF THE (B)(6) (TBE AORTIC COMPONENT), AND THE CTAG DEVICE IMMEDIATELY DISTAL TO THE TBE AORTIC COMPONENT (B)(6) DID NOT MAINTAIN APPOSITION TO THE AORTA RESULTING IN A TYPE 3 ENDOLEAK. IT IS UNKNOWN IF THERE WAS FALSE LUMEN EXPANSION. IT IS UNKNOWN IF THERE WAS A RUPTURE. DURING THE REINTERVENTION, ANOTHER CTAG DEVICE WAS IMPLANTED TO OVERLAP THE DEVICES AND THE ENDOLEAK

  Patient problems: Clinical Endoleak; Low Blood Pressure/ Hypotension; Mediastinal Shift; Pain; Vascular Dissection

  MAUDE report 24680449 ↗
• DeathFeb 8, 2026Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF DISSECTIONS OF THE ASCENDING AORTA (AAA-2402): ON (B)(6) 2025, THE SUBJECT WAS TO BE IMPLANTED WITH THE INVESTIGATIONAL GORE® ASCENDING STENT GRAFT. A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT AND SIDE BRANCH) WAS ALSO IMPLANTED DURING THE PROCEDURE. ON THE SAME DAY OF THE PROCEDURE, (B)(6) 2025, THE PATIENT HAD A BASILAR ARTERY STROKE THAT RESULTED IN DEATH. THE CAUSE OF THE STROKE AND DEATH ARE UNKNOWN.

  Patient problems: Stroke/CVA

  MAUDE report 24288365 ↗
• MalfunctionJan 17, 2025Positioning Problem; Positioning Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS IN ZONE 0. DURING IMPLANTATION OF THE AORTIC COMPONENT (AC), THE PHYSICIAN HAD DIFFICULTIES ALIGNING THE PORTAL TO THE BRANCH VESSEL DUE TO TORTUOSITY IN THE AORTIC ARCH. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO ALIGN THE PORTAL BY BRINGING THE DEVICE BACK INTO THE DESCENDING AORTA TO REORIENT THE PORTAL AND APPLYING TORQUE AS THE DEVICE MOVED UP INTO THE AORTIC ARCH. DURING ONE OF THOSE MOVEMENTS INTO THE DESCENDING AORTA, THE PROXIMAL END OF THE AC PREMATURELY DEPLOYED. IT IS LIKELY THAT THE OVER TORQUING OF THE AORTIC COMPONENT RESULTED IN THE PREMATURE PARTIAL DEPLOYMENT. THE PHYSICIAN PULLED THE DEVICE BACK INTO THE SHEATH AND REMOVED THE AC AND SHEATH TOGETHER. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF A SECOND AORTIC COMPONENT. THE FIRST AORTIC COMPONENT WAS DISCARDED AT THE SITE. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183536 ↗
• DeathJan 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A REINTERVENTION TOOK PLACE TO FIX A SUSPECTED ENDOLEAK ON AN EXISTING COOK GRAFT. A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) BRANCH COMPONENT WAS ADVANCED TO THE LEVEL OF THE DESCENDING THORACIC AORTA, JUST BELOW THE AORTIC ARCH. THE FSA NOTED THE PHYSICIAN HAVING DIFFICULTY ADVANCING THE DEVICE THROUGH THE COOK GRAFT AND SUGGESTED PULLING THE DEVICE DOWN A BIT TO CHECK FOR WIRE WRAP. THE PHYSICIAN PULLED THE DEVICE DOWN, AND INSPECTED FOR WIRE WRAP, BUT FOUND NONE; BUT BEFORE READVANCING, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PATIENT CODED. CPR WAS ADMINISTERED, BUT THE PATIENT DIED. A TRANSESOPHAGEAL ECHO (TEE) PROBE WAS INSERTED AND SHOWED A LOT OF BLOOD IN THE CHEST CAVITY.

  Patient problems: Cardiac Arrest

  MAUDE report 21133271 ↗
• MalfunctionMar 26, 2024Malposition of Device; Device Damaged by Another Device; Malposition of Device; Device Damaged by Another Device

  ON (B)(6) 2024, THE PATIENT WAS TREATED FOR AN AORTIC DISSECTION WITH THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) IN ZONE 0. ON (B)(6) 2024, THE PHYSICIAN ATTEMPTED TO IMPLANT TWO TBE DEVICES. THE FIRST WAS INTENDED FOR ZONE 2 AND THE OTHER, FOR ZONE 0. THE TBE IN ZONE 2 WAS IMPLANTED SUCCESSFULLY. WHILE ATTEMPTING TO IMPLANT THE TBE AORTIC COMPONENT IN ZONE 0, THE PHYSICIAN ENCOUNTERED WIRE WRAP WHILE ADVANCING THE AORTIC COMPONENT INTO THE ASCENDING AORTA. TO REMOVE THE WIRE WRAP, THE PHYSICIAN PULLED THE DEVICE BACK INTO THE DESCENDING THORACIC AORTA. DURING THIS BACKWARD MOVEMENT OF THE DEVICE, THE DEPLOYMENT LINE THAT CONNECTS THE PROXIMAL AND DISTAL DEPLOYMENT SLEEVES GOT CAUGHT ON ONE OF THE FLARED APICES OF THE TBE SIDE BRANCH COMPONENT. AS THE PHYSICIAN CONTINUED TO PULL THE DEVICE INTO THE DESCENDING AORTA, THIS INTERACTION CAUSED THE PROXIMAL END OF THE TBE AORTIC COMPONENT TO DEPLOY WITHIN THE DESCENDING THORACIC AORTA. THE PHYSICIAN ACCEPTED THE LOCATION AND COMPLETED THE DEPLOYMENT INSIDE A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL THAT HAD BEEN DEPLOYED EARLIER IN THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN BELIEVES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980520 ↗
• InjuryFeb 8, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2024, PATIENT UNDERWENT A THORACIC ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) IN ZONE 2. ON (B)(6) 2024, PATIENT HAD VISION CHANGES, AND A CT SCAN WAS PERFORMED WHICH SHOWED NO GRAFT MATERIAL WAS COVERING THE CAROTID, BUT PROCEEDED WITH AN ANGIO AS A PRECAUTION. IT WAS NOTED THERE WAS NO LCA PALPABLE PULSE. ON (B)(6) 2024, PATIENT UNDERWENT REINTERVENTION SURGERY IN WHICH PHYSICIAN STENTED IT WITH ICAST. PATIENT TOLERATED THE PROCEDURE. PHYSICIAN ATTRIBUTES THIS ISSUE TO PATIENT PREVIOUSLY HAVING A SURGICALLY REPAIRED HEMIARCH, AND THE PROXIMAL APICES OF THE TBE DEVICE MUST HAVE CREATED A FLOW DISTURBANCE IN THE CAROTID.

  Patient problems: Visual Impairment

  MAUDE report 18671030 ↗
• InjuryJul 17, 2023Positioning Failure; Positioning Failure

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM. WHILE ATTEMPTING TO INSERT A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AND 24FR DRYSEAL SHEATH INTO THE PATIENT'S EXTERNAL ILIAC ARTERY, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING, RESULTING IN A DISSECTION OF THE RIGHT EXTERNAL ILIAC. THE DEVICES WERE REMOVED, AND THE DISSECTION WAS REPAIRED WITH A VIABAHN. THE PHYSICIAN THEN TRIED TO USE A SMALLER DEVICE/SHEATH COMBINATION, AND WAS SUCCESSFULLY ABLE TO COMPLETE THE PROCEDURE. THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AND DRYSEAL SHEATH WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333429 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P210032. One submission often covers many models, so check the product and lot details in each record.

• Z-2672-2026 · May 19, 2026 · Open, Classified
  GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB08