GORE TAG Thoracic Branch Endoprosthesis TE4546ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132654345), received between Sep 10, 2025 and Apr 3, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 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 AORTIC EXTENDER AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS) USING A GORE®¿DRYSEAL FLEX INTRODUCER SHEATH AND A GORE® TRI-LOBE BALLOON CATHETER TO TREAT AN ASCENDING THORACIC DISSECTION. REPORTEDLY DURING THE PROCEDURE WHILE RETRACTING THE DELIVERY CATHETER OF THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER THE DEVICE MOVED DISTALLY AND PARTIALLY COVERED THE INNOMINATE ARTERY. THE PHYSICIAN IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN THE INNOMINATE ARTERY TO MAINTAIN PATENCY. THEN THE PHYSICIAN IMPLANTED A SECOND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE. POST PROCEDURE IMAGES REVEALED A TYPE B DISSECTION FROM IMPLANTED GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER EXTENDING DOWN INTO THE ILIAC ARTERY. THE PHYSICIAN IS NOT TREATING THE DISSECTION AT THIS TIME. THE EVENT IS ONGOING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 24780051 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) TO TREAT A DISSECTION UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT, SIDE BRANCH AND AORTIC EXTENDER). PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE ON A PRIOR TEVAR TO TREAT AN ENDOLEAK AND DISSECTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). REPORTEDLY, THERE WAS A TYPE 1A ENDOLEAK FROM THE LEFT SUBCLAVIAN ARTERY WITH THE SIDE BRANCH AND A DISTAL EXTENSION OF THE TYPE B DISSECTION FROM THE AORTIC COMPONENT. THE ENDOLEAK IS POSSIBLY DUE TO A FENESTRATION THAT WAS NOT SEALED PERFECTLY ON THE PROXIMAL SIDE DURING THE ORIGINAL PROCEDURE AND THE DISTAL SIDE WHERE THE DISSECTION MIGHT NOT HAVE BEEN FULLY COVERED. PHYSICIAN IS UNSURE OF THE CAUSE, IF ITS A NEW FENESTRATION OR SIMPLY DID NOT COVER IT ENOUGH DURING THE INITIAL PROCEDURE AS THERE IS FALSE LUMEN PROXIMALLY (ANEURYSM SIZE UNKNOWN) AND TYPE B DISSECTION DISTALLY, WHICH PHYSICIAN FIXED BY ADDING 10-15 TERUMO COILS PROXIMALLY IN THE FALSE LUMEN, JUST OUTSIDE THE LEFT SUBCLAVIAN

  Patient problems: Aneurysm expansion

  MAUDE report 23015388 ↗

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