GORE TAG Thoracic Branch Endoprosthesis TAC123415ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132654192), received between Jan 22, 2023 and Jun 1, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

• InjuryJun 1, 2026Failure to Advance

  ON (B)(6) 2026, THE PATIENT UNDERWENT A TEVAR PROCEDURE TO TREAT A DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE PATIENT HAD A DEBRANCHING PROCEDURE FOR THE INNOMINATE ARTERY AND CAROTID ARTERY THREE DAYS PRIOR IN PREPARATION FOR THE TEVAR PROCEDURE. REPORTEDLY, THE TBE AORTIC COMPONENT COULD NOT BE ADVANCED TO THE TARGET LOCATION. THE PHYSICIAN ATTEMPTED TO USE A NEW TBE AORTIC COMPONENT AND STILL COULD NOT ADVANCE THE DEVICE TO THE TARGET LOCATION. THE CAUSE OF THE ADVANCEMENT ISSUES IS UNKNOWN. SUBSEQUENTLY, THE PHYSICIAN ELECTED TO USE TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) TO COMPLETE THE PROCEDURE. AS THERE WERE ADVANCEMENT ISSUES WHEN INSERTING DEVICES FROM THE PATIENT'S GROIN, THE PHYSICIAN RE-OPENED THE PATIENT'S CHEST FROM THE DEBRANCH PROCEDURE AND DELIVERED THE FIRST CTAG DEVICE THROUGH THE SURGICAL GRAFT IN THE ASCENDING AORTA, LANDING DISTAL TO THE ANASTOMOSIS OF THE SURGICAL GRAFT FROM THE DEBRANCH PROCEDURE. THE SECOND CTAG WAS DELIVERED SUCCESSFULLY FROM THE GROIN; HOWEVER, THE LEFT SUBCLAVIAN ARTERY (LSA) WAS COVERED, SO THE PHYSICIAN COMPLETED A CAROTID-SUBCLAVIAN BYPASS. THE PROCEDURE WAS SUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353951 ↗
• InjuryMay 29, 2026Failure to Advance

  ON (B)(6) 2026, THE PATIENT UNDERWENT A TEVAR PROCEDURE TO TREAT A DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE PATIENT HAD A DEBRANCHING PROCEDURE FOR THE INNOMINATE ARTERY AND CAROTID ARTERY THREE DAYS PRIOR IN PREPARATION FOR THE TEVAR PROCEDURE. REPORTEDLY, THE TBE AORTIC COMPONENT COULD NOT BE ADVANCED TO THE TARGET LOCATION. THE PHYSICIAN ATTEMPTED TO USE A NEW TBE AORTIC COMPONENT AND STILL COULD NOT ADVANCE THE DEVICE TO THE TARGET LOCATION. THE CAUSE OF THE ADVANCEMENT ISSUES IS UNKNOWN. SUBSEQUENTLY, THE PHYSICIAN ELECTED TO USE TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) TO COMPLETE THE PROCEDURE. AS THERE WERE ADVANCEMENT ISSUES WHEN INSERTING DEVICES FROM THE PATIENT'S GROIN, THE PHYSICIAN RE-OPENED THE PATIENT'S CHEST FROM THE DEBRANCH PROCEDURE AND DELIVERED THE FIRST CTAG DEVICE THROUGH THE SURGICAL GRAFT IN THE ASCENDING AORTA, LANDING DISTAL TO THE ANASTOMOSIS OF THE SURGICAL GRAFT FROM THE DEBRANCH PROCEDURE. THE SECOND CTAG WAS DELIVERED SUCCESSFULLY FROM THE GROIN; HOWEVER, THE LEFT SUBCLAVIAN ARTERY (LSA) WAS COVERED, SO THE PHYSICIAN COMPLETED A CAROTID-SUBCLAVIAN BYPASS. THE PROCEDURE WAS SUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25332301 ↗
• MalfunctionMar 13, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT AND SIDE BRANCH) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A THORACIC DISSECTION WITH AN ANEURYSM COMPONENT. IT WAS REPORTED THAT AFTER PULLING THE DEPLOYMENT LINE OF THE TBE AORTIC COMPONENT, THE DEPLOYMENT WAS INCOMPLETE (DEVICE ONLY DEPLOYED AT 50%). THE PHYSICIAN DELIVERED A PTA 12MM BALLOON AND SLOWLY BALLOONED THE DEVICE AND IT FULLY DEPLOYED. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THE PROCEDURE CONCLUDED WITH NO FURTHER SEQUELA. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THERE WERE NO ANATOMIC CONSTRAINTS AND NO ANATOMY TORTUOSITY.

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

  MAUDE report 24599649 ↗
• InjuryJan 5, 2026Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS IN ZONE 2. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO ADDRESS A TYPE 1A ENDOLEAK. THE PHYSICIAN IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ALONG WITH A GORE® VIABAHN® ENDOPROSTHESIS TO RESOLVE THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 23966701 ↗
• MalfunctionApr 25, 2025Activation Failure; Activation Failure

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS IN ZONE 2. IT WAS REPORTED THAT THERE WAS A DEPLOYMENT FAILURE. THE PHYSICIAN PULLED THE DEPLOYMENT LINE FASTER THAN THE FSA SUGGESTED. THE BACK HALF OF THE STENT WAS UNABLE TO BE DEPLOYED. THE PHYSICIAN BALLOONED THE STENT TO RESOLVE THE ISSUE. THERE WERE NO ANATOMIC CONSTRAINTS. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT EXCESSIVE WIRE WRAP OF THE PIGTAIL AND DEVICE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914196 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 TYPE B DISSECTION AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT HE BELIEVES THE DISSECTION HAS EXTENDED DISTALLY AND WANTS TO EXTEND COVERAGE DISTALLY TO COVER ANOTHER POSSIBLE FENESTRATION IN THE TRUE FALSE LUMEN SPACE. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION AND TWO ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED DISTALLY TO EXTEND COVERAGE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 16595272 ↗
• InjuryJan 22, 2023Adverse 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 A ZONE 0 THORACIC AORTIC ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS EXTREMELY TORTUOUS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE POST PROCEDURE. THE PHYSICIAN ALSO NOTED THAT IT MAY HAVE OCCURRED INTRA PROCEDURE. REPORTEDLY THE CAUSE OF THE STROKE IS UNKNOWN, BUT IT WAS SUSPECTED TO BE RELATED TO WIRE AND DEVICE MANIPULATION. DUE TO THE ANATOMICAL TORTUOSITY, THERE WAS ALSO DIFFICULTY REPORTED WHILE ATTEMPTING TO ALIGN THE PORTAL OF THE THORACIC BRANCH AORTIC COMPONENT TO THE OUTER CURVE IN AORTIC ZONE 0. IT WAS REPORTED THAT THE PATIENT REMAINED IN THE HOSPITAL POST PROCEDURE FOR STROKE COMPLICATIONS INCLUDING APHASIA. ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT THE PATIENT'S APHASIA WAS SIGNIFICANTLY IMPROVED, AND THE PATIENT WAS WALKING WITH THE PHYSICAL THERAPIST. THE PATIENT WAS REPORTEDLY DISCHARGED TO HOME ON OR ABOUT (B)(6) 2022.

  Patient problems: Stroke/CVA

  MAUDE report 16221805 ↗

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