GORE TAG Thoracic Branch Endoprosthesis TAC083115ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132654079), received between Sep 13, 2023 and Jul 15, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 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 ZONE 2 PSEUDOANEURYSM AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT DEVELOPED AN INFECTION WITHIN THE TBE DEVICES AND THE DEVICES WERE EXPLANTED. THE CAUSE OF THE INFECTION WAS NOT KNOWN. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 22516121 ↗
• InjuryOct 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, PATIENT UNDERWENT A ZONE-2-LCC ENDOVASCULAR PROCEDURE TO TREAT A PSEUDOANEURYSM AND PENETRATING AORTIC ULCER UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. THERE WERE NO ISSUES DURING THE PROCEDURE. NO ISSUES NOTED WITH THE DEVICES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT TOLERATED THE PROCEDURE. AFTER THE PROCEDURE ON THE SAME DAY , PATIENT SUFFERED AN ISCHEMIC STROKE. HOSPITAL STAFF IS NOT AWARE IF THIS OCCURRED DURING INTRA-OP OR POST-OP, AS PATIENT WAS UNDER ANESTHESIA. FSA REPORTS PATIENT IS ALIVE, BUT DOES NOT HAVE FURTHER INFORMATION ON CURRENT PATIENT STATUS. PHYSICIAN DOES NOT KNOW WHAT CONTRIBUTED TO THIS STROKE EVENT. NO FURTHER PATIENT INFORMATION IS AVAILABLE. NO FURTHER INFORMATION WILL BE DISCLOSED FROM HOSPITAL.

  Patient problems: Ischemia Stroke

  MAUDE report 18023280 ↗
• InjuryOct 4, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM AT THE LEVEL OF THE LEFT SUBCLAVIAN ARTERY WITH A COMORBID PENETRATING AORTIC ULCER. TREATMENT WAS PERFORMED USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). IT WAS NOTED THAT THE PATIENT'S PATHOLOGY WAS HIGHLY CONCERNING AND SUSPECTED TO BE VULNERABLE TO IMMINENT RUPTURE. THE PATIENT'S ANATOMY REPORTEDLY APPEARED FAVORABLE FOR TBE PLACEMENT, AND A TBE AORTIC COMPONENT AND SIDE BRANCH DEVICE WERE IMPLANTED. A FINAL ANGIO RUN WAS PERFORMED AND IT WAS REPORTED THAT THE LESION APPEARED SEALED. FOLLOWING THE INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT'S PAIN HAD IMPROVED, BUT HAD NOT COMPLETELY RESOLVED. HOWEVER, SINCE THERE WAS IMPROVEMENT, THE PATIENT WAS DISCHARGED. ON AN UNKNOWN DATE, ON OR AROUND (B)(6) 2023, THE PATIENT PRESENTED WITH SEVERE PAIN. A CTA WAS PERFORMED AND A SUSPECTED PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED AND A TBE AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT THE PROXIMAL TYPE I ENDOLEAK. THERE WERE NO REPORTED ISSUES DURING THE CASE AND A FINAL ANGIO RUN APPEARED TO SHOW SUCCESSFUL TREATMENT OF THE ENDOLEAK.

  Patient problems: Abdominal Pain; Clinical Endoleak

  MAUDE report 17873766 ↗
• 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 17736644 ↗

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