GORE TAG Conformable Thoracic Endoprosthesis TGU282815Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132618057), received between Jan 19, 2022 and Jan 19, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 THE PATIENT UNDERWENT PART ONE OF A STAGED PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG) IN THE GORE® EXCLUDER® (B)(6) CLINICAL TRIAL. ON (B)(6) 2022 A RETROPERITONEAL HEMATOMA WAS OBSERVED. IT WAS REPORTED THAT THE HEMATOMA WAS STUDY PROCEDURE RELATED. ON (B)(6) 2022 HEMATOMA EVACUATION WAS PERFORMED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE AND IT WAS REPORTED THAT COMPUTED TOMOGRAPHY IMAGING WILL BE PERFORMED TO EVALUATE THE PLACEMENT OF THE CTAG DEVICE PRIOR TO COMPLETING THE (B)(6) PHASE OF THE STAGED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13300431 ↗

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-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
• Z-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm