GORE TAG Thoracic Endoprosthesis TGT2810Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132613595), received between Jun 21, 2023 and Jun 21, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2011, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A RETROGRADE TYPE A DISSECTION AND ULP USING THREE GORE® TAG® THORACIC ENDOPROSTHESES. AFTER ALL DEVICES WERE IMPLANTED, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. THE PHYSICIAN DECIDED TO MONITOR THIS ENDOLEAK. ON AN UNKNOWN DATE, A FOLLOW-UP EXAM REVEALED THE PROXIMAL TYPE I ENDOLEAK AND THE FALSE LUMEN ENLARGEMENT. NO NEW ENTRY TEAR WAS FOUND IN FALSE LUMEN. IT WAS UNKNOWN IF THERE WAS PERSISTENT FALSE LUMEN PERFUSION. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED PROXIMALLY. THE ENDOLEAK WAS RESOLVED. IN ADDITION, IT WAS ALSO REPORTED THAT PHYSICIAN DID NOT REPORT ADDITIONAL INFORMATION ON CAUSE OF THE TYPE 1 ENDOLEAK AND THE FALSE LUMEN ENLARGEMENT OCCURRED DUE TO THE TYPE 1 ENDOLEAK.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Clinical Endoleak

  MAUDE report 17171259 ↗

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-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0291-2021 · 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