GORE TAG Thoracic Branch Endoprosthesis TAC123115ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132654178), received between May 2, 2023 and May 2, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2023, THIS PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF A ZONE 2 TYPE B DISSECTION WITH MALPERFUSION, AND WAS IMPLANTED WITH A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) WITH COVERAGE OF THE LEFT SUBCLAVIAN ARTERY (LSA). THREE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICES) WERE IMPLANTED AS BRANCH DEVICES WITHIN THE LSA AS THE APPROPRIATELY SIZED SIDE BRANCH DEVICES WERE NOT AVAILABLE. ADDITIONALLY, IT WAS REPORTED THAT DURING ADVANCEMENT OF THE TBE DEVICE, THE PHYSICIAN ENCOUNTERED ALOT OF DIFFICULTY POSITIONING THE TBE DEVICE TO ALIGN PROPERLY TO THE GREATER CURVE. THE TBE DEVICE HAD BEEN WITHDRAWN BACK DOWN TO THE DESCENDING THORACIC AORTA AT LEAST TEN TIMES IN AN ATTEMPT TO GET THE PORTAL TO LINE UP; AS IT KEPT FLIPPING TO THE LESSER CURVE OF THE AORTA AS OPPOSED TO THE GREATER CURVE. THE DEVICE WAS ALSO COMPLETELY REMOVED FROM THE SHEATH AND REINSERTED IT BACK INTO THE SHEATH IN HOPES OF GETTING IT TO TRACK AND ALIGN BETTER. ADDITIONALLY, IT WAS REPORTED THAT DURING ALL THE EXCESSIVE DEVICE MANIPULATION, THAT THE LUNDERQUIST WIRE PARKED IN THE ASCENDING THORACIC AORTA HAD BEEN DRAGGED BACK TO THE LEVEL OF THE DESCENDING AO

  Patient problems: Vascular Dissection

  MAUDE report 16856040 ↗

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