GORE TAG Thoracic Branch Endoprosthesis TSB080806ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132654352), received between Jun 8, 2023 and Aug 21, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2025, DURING AN ENDOVASCULAR PROCEDURE IT WAS REPORTED THAT POST DEPLOYMENT OF THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (SIDE BRANCH COMPONENT TSB). WHEN TRYING TO WITHDRAW THE DELIVERY CATHETER, THE NOSE CONE CAME OFF. THE PHYSICIAN SNARED THE NOSE CONE AND IN THE PROCESS OF REMOVING THE ARTIFACT FROM THE PATIENT, THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) WAS PULLED BACK AND SEAL WAS LOST AND A GORE® TAG® THORACIC BRANCH AORTIC EXTENDER WAS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 22866197 ↗
• InjuryJun 8, 2023Complete Blockage; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Complete Blockage; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 2 THORACIC AORTIC ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). IT WAS REPORTED THAT THE CASE WAS WITH A SIDE BRANCH INTO LEFT SUBCLAVIAN ARTERY (LSA). REPORTEDLY, THE ACCESS AND THE DEPLOYMENT OF THE TBE AORTIC COMPONENT AND TBE SIDE BRANCH TSB080806/26297332 WERE PERFORMED WITH NO REPORTED ISSUES. DURING THE BALLOONING OF THE SIDE BRANCH DEVICE WITH A CODA BALLOON, THE PROXIMAL END OF TSB WAS INFLATED PAST VESSEL PROFILE. A LSA ANGIOGRAPHY WAS PERFORMED, AND A RUPTURE WAS NOTICED. ACCORDING TO THE PHYSICIAN, THE OVER BALLOONING CAUSED THE VESSEL RUPTURE (CODED: 1400-E:-RUPTURE EVENTS - OTHER/UNKNOWN). A SECOND SIDE BRANCH (TSB080806/26265891) WAS INSERTED TO THE LEVEL OF THE VERTEBRAL ARTERY. THE DEPLOYMENT WAS AS EXPECTED. ANOTHER ANGIO SCAN WAS PERFORMED, AND THE RUPTURE WAS STILL PRESENT. A THIRD SIDE BRANCH (TSB080806/26265890) WAS DEPLOYED COVERING THE VERT TO THE LEVEL OF THE INTERNAL MAMMARY ARTERY (IMA). THE POST DEPLOYMENT ANGIOGRAPHY SHOWED NO RUPTURE WITH GOOD OUTFLOW. POST OP PATIENT HAD PALPABLE PULSE IN THE ARM AND NO SIGNS OF NEURO DEFICITS. REPORTEDLY, 14 HRS POST OP ( ~4 AM),

  Patient problems: Aneurysm; Reduced Blood Flow; Vascular Dissection

  MAUDE report 17094806 ↗

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