GORE TAG Thoracic Branch Endoprosthesis TAC082815ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132654055), received between Aug 28, 2023 and Aug 28, 2023 — classified as 1 injury.

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.

• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION WITH AN ANEURYSMAL COMPONENT USING ZONE 2 PLACEMENT OF A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AORTIC COMPONENT AND DISTAL EXTENSION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). IT WAS NOTED THAT THE AORTIC ARCH HAD A DOUBLE BEND. IT WAS REPORTED THAT THE TBE DEVICE WAS WELL PLACED WITH THE PORTAL AT THE DISTAL EDGE OF THE PATIENT'S LEFT SUBCLAVIAN ARTERY (LSA). THE PROXIMAL END OF THE DEVICE WAS STILL 2-3 CM FROM THE PATIENT'S LEFT COMMON CAROTID ARTERY (LCCA). NO BALLOONING WAS PERFORMED SINCE THIS WAS FOR TREATMENT OF A TYPE B DISSECTION, AND IT WAS REPORTED THAT NO PROXIMAL EXTENSION WAS PERFORMED AS IT DID NOT APPEAR NECESSARY. IT WAS REPORTED THAT THE CTAG A/C DEVICE WAS PLACED DISTALLY AND ENDED IN THE MID-DESCENDING THORACIC AORTA SO AS TO LIMIT AORTIC COVERAGE. THE DISSECTION EXTENDED TO THE CELIAC ARTERY. FINAL ANGIOGRAMS SHOWED CONTINUED FILLING OF THE FALSE LUMEN CREATING A TYPE IB DISSECTION. THE PHYSICIAN CHOSE TO WATCH AND WAIT. ON OR AROUND (B)(6) 2023, FOLLOW-UP CTA IMAGING SHOWED CONTINUED FILLING OF THE FALSE

  Patient problems: Aneurysm expansion

  MAUDE report 17635061 ↗

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