GORE TAG Thoracic Branch Endoprosthesis TAC123420ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132654208), received between Apr 30, 2026 and Apr 30, 2026 — classified as 1 malfunction.

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

• MalfunctionApr 30, 2026Material Frayed; Off-Label Use; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT WAS TREATED FOR A ZONE 0 CHRONIC DISSECTION USING A PHYSICIAN MODIFIED GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE DEVICE WAS MODIFIED TO CREATE FENESTRATIONS FOR THE LEFT COMMON CAROTID AND LEFT SUBCLAVIAN. IN THE PROCESS OF PERFORMING THIS MODIFICATION, THE PRIMARY SLEEVE WAS OPENED FOR A 3 CM SEGMENT ON THE SIDE OF THE DEVICE ADJACENT TO THE PORTAL. AFTER ADVANCING THE DEVICE TO THE TRANSVERSE THORACIC AORTA, THEY REALIZED THE DEVICE HAD WIRE WRAP WITH THE INNOMINATE WIRE. THEY ROTATED 2-3 TIMES COUNTER-CLOCKWISE, REALIZED THAT WAS THE WRONG DIRECTION, AND ROTATED THE OTHER WAY. AFTER 10 MINUTES, THE TBE WAS ABLE TO BE ADVANCED THROUGH THE SHEATH. ONCE IN POSITION, THEY PULLED THE DEPLOYMENT LINE. HOWEVER, THE DEVICE DID NOT DEPLOY AND REMAINED CONSTRAINED. THE PHYSICIAN TRIED TO SNARE THE PARTIALLY OPEN END OF THE TBE DEVICE, AND PULL IT BACK INTO THE DSF, BUT AFTER 45 MINUTES THEY ABANDONED THIS. THEY THEN REMOVED THE DSF AND TBE TOGETHER. THE RIGHT EXTERNAL AND COMMON ILIACS WERE DAMAGED BY THE GRAFT AND REPAIRED USING A PATCH ENDARTERECTOMY. THE PROCEDURE WAS ABORTED, AND NO DEVICES WERE IMPLANTED. THE PA

  Patient problems: Unspecified Vascular Problem

  MAUDE report 25049241 ↗

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