GORE TAG Thoracic Branch Endoprosthesis TAC123720ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132654222), received between Apr 9, 2026 and Apr 9, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Device Endoleak” (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.

• InjuryApr 9, 2026Use of Device Problem; Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING A PHYSICIAN-MODIFIED GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) IN ZONE 0 OF THE THORACIC AORTA. ON (B)(6) 2026, THE FIELD SALES ASSOCIATE (FSA) WAS MADE AWARE THAT THE PHYSICIAN WAS PLANNING TO REINTERVENE ON THE PATIENT DUE TO A POTENTIAL TYPE 1A AND TYPE 2 ENDOLEAKS. REPORTEDLY, THE TYPE 1A ENDOLEAK WAS CAUSED BY THE PHYSICIAN UNDERSIZING THE TBE IN THE PATIENT'S ANATOMY. IT IS UNKNOWN IF THERE WAS ANY ANEURYSM ENLARGEMENT ASSOCIATED WITH THE POTENTIAL ENDOLEAKS. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO ADD PROXIMAL EXTENSION TO THE PREVIOUSLY IMPLANTED TBE IN THE ASCENDING AORTA UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). REPORTEDLY DURING THE PROCEDURE, THE PRIMARY DEPLOYMENT LINE BROKE, BUT THE BACKUP HATCH WAS USED TO SUCCESSFULLY COMPLETE DEPLOYMENT. WHEN THE DEPLOYMENT LINE BROKE, THE DEVICE PARTIALLY "FLOWERED", AND THE PATIENT'S BLOOD PRESSURE DROPPED TO ZERO DUE TO AN INCOMPETENT AORTIC VALVE ACCORDING TO THE PHYSICIAN. ONCE THE DEVICE WAS DEPLOYED SUCCESSFULLY USING THE BACKUP HATCH, THE PATIENT'S BLOOD PRESSURE RECOVERE

  Patient problems: Clinical Endoleak

  MAUDE report 24829445 ↗

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