GORE TAG Conformable Thoracic Endoprosthesis TGU282810Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132618026), received between Jul 3, 2018 and Nov 15, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED THAT AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS EXPLANTED AND DISCARDED AT THE SITE. THE INVESTIGATIVE PROCESS RETURNED NO ADDITIONAL INFORMATION.

  Patient problems: No Information

  MAUDE report 8073475 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2017, THIS PATIENT WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2018, GORE MEDICAL DEVICE TRACKING RECEIVED DOCUMENTATION FROM THE IMPLANTING HOSPITAL THAT THE DEVICE HAD BEEN EXPLANTED AND DISCARDED AT THE SITE. THE DATE AND REASON FOR EXPLANT WAS NOT PROVIDED. FURTHER INVESTIGATION IS UNDERWAY.

  Patient problems: Aneurysm; No Information

  MAUDE report 7719604 ↗
• InjuryJul 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE PATIENT WAS CONVERTED TO OPEN REPAIR AND THE DEVICES WERE EXPLANTED THIS SAME DAY. THE DEVICES WERE DISCARDED AT THE SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658174 ↗

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