GORE TAG Conformable Thoracic Endoprosthesis TGU454510Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132617746), received between Apr 22, 2019 and Jul 26, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

6 other recalls cover devices cleared under the same FDA submission (P040043); 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.

• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, A PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG/AC) TO TREAT ASCENDING AORTIC ANEURYSM. THE PATIENT HAD ASCENDING AORTIC ANEURYSM AND PERFORMED A HEART TRANSPLANT PREVIOUSLY. DURING THE PROCEDURE, A TGMR373710 CTAG/AC WAS IMPLANTED AND DEPLOYED AS PLANNED. DUE TO THE LARGE SIZE OF THE ANEURYSM, THE STENT MOVED BACKWARDS AFTER IMPLANTATION. THE PHYSICIAN CONTINUED TO IMPLANT CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS (TGU4545110) TO RELINE THE TGMR373710. THE PATIENT TOLERATED THE PROCEDURE AND TRANSFERRED TO ICU FOR MONITOR. ON JULY 12, CLINICIAN FEED BACKED THAT THE PATIENT HAD CEREBRAL INFARCTION. THE PHYSICIAN SUSPECTED IT MAY RELATE TO PATIENT'S CONDITION, NOT TO THE PRODUCT.

  Patient problems: Neurogenic Shock

  MAUDE report 19835618 ↗
• InjuryApr 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE USING AN FDA IMPLANTED AND EXPLANTED DEVICES FORM: IT WAS REPORTED THAT A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG) WAS USED TO TREAT AN UNKNOWN ETIOLOGY. ON (B)(6) 2019 THE CTAG DEVICE (LOT #16103109) WAS REPORTEDLY IMPLANTED AND EXPLANTED. THE FDA IMPLANTED AND EXPLANTED DEVICES FORM LISTS "PATIENT ANATOMY" AS THE REASON FOR ACTION. NO FURTHER EVENT INFORMATION WAS PROVIDED. FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8538142 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040043. One submission often covers many models, so check the product and lot details in each record.

• Z-0291-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-2052-2020 · Dec 17, 2019 · Terminated
  Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
• Z-0048-2018 · Sep 25, 2017 · Terminated
  GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
• Z-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm
• Z-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm