GORE TAG Thoracic Endoprosthesis TGT3720Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132613687), received between Jan 8, 2020 and Jun 15, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2025Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESIS DEVICES. BOTH TAG DEVICES WERE IMPLANTED IN THE DESCENDING AORTA AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2020, THE PATIENT UNDERWENT AORTIC ARCH REPLACEMENT AND OPEN STENT GRAFT PLACEMENT TO TREAT A PREEXISTING AORTIC ARCH ANEURYSM. ON (B)(6) 2025, CT EXAMINATION CONFIRMED THAT THE DISTAL TAG DEVICE HAD MIGRATED TO THE PROXIMAL SIDE, RESULTING IN A DISTAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). THE CTAGAC WAS DEPLOYED IN THE DISTAL SIDE TO TREAT THE DISTAL TYPE I ENDOLEAK. DURING THE DEPLOYMENT AND BALLOON MOLDING, THE DEVICE MOVED TO PROXIMAL SIDE, BUT NO ENDOLEAK WAS OBSERVED. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 22208667 ↗
• InjuryJan 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING GORE® TAG® THORACIC ENDOPROSTHESIS FOR DESCENDING AORTIC ANEURYSM USING ELEPHANT TRUNK TECHNIQUE. ON (B)(6) 2023, TYPE IIIB ENDOLEAK WAS CONFIRMED BY ANGIOGRAPHY. IT WAS REPORTED THAT THE DATE OF ENDOLEAK ONSET IS UNKNOWN. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION. TWO ADDITIONAL STENT GRAFTS WERE DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYCISIAN STATED THE FOLLOWING. IT APPEARS THAT TEAR APPEARED IN THE GRAFT DUE TO FRICTION CAUSED BY THE PULSATION, RESULTING IN TYPE IIIB.

  Patient problems: Clinical Endoleak

  MAUDE report 18475710 ↗
• InjuryFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, THE PATIENT PRESENTED WITH A MID-DESCENDING THORACIC AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG A/C). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017, THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK FROM THE PREVIOUSLY PLACED DEVICE AND UNDERWENT REINTERVENTION UTILIZING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG). THE TAG DEVICE WAS EXTENDED TO THE LEFT SUBCLAVIAN ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK AND UNDERWENT REINTERVENTION UTILIZING A CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS (CTAG). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A CONTINUED TYPE 1A ENDOLEAK AND UNDERWENT REINTERVENTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE DEVICE WAS PLACED TO PARTIALLY COVER THE LEFT SUBCLAVIAN ARTERY DUE TO THE CONTINUED TYPE 1A ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022. THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK AND UNDERWENT A CAROTID-CAROTID AND CAROTID-SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596503 ↗
• InjuryFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, THE PATIENT PRESENTED WITH A MID-DESCENDING THORACIC AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG A/C). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017, THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK FROM THE PREVIOUSLY PLACED DEVICE AND UNDERWENT REINTERVENTION UTILIZING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG). THE TAG DEVICE WAS EXTENDED TO THE LEFT SUBCLAVIAN ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK AND UNDERWENT REINTERVENTION UTILIZING A CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS (CTAG). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A CONTINUED TYPE 1A ENDOLEAK AND UNDERWENT REINTERVENTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE DEVICE WAS PLACED TO PARTIALLY COVER THE LEFT SUBCLAVIAN ARTERY DUE TO THE CONTINUED TYPE 1A ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022. THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK AND UNDERWENT A CAROTID-CAROTID AND CAROTID-SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596424 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING TWO GORE® TAG® THORACIC ENDOPROSTHESES BY FROZEN ELEPHANT TRUNK TECHNIQUE FOR DESCENDING AORTIC ANEURYSM. DURING THE PROCEDURE, IT WAS NOTED A SLIGHT TYPE III ENDOLEAK. THE PHYSICIAN CHOSE TO MONITOR THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, A FOLLOW-UP EXAMINATION REVEALED THE DISEASE PROGRESSION INTO THE DISTAL SIDE. THE DISTAL SIDE OF THE DEVICE BECAME ANEURYSMAL. ACCORDING TO THE INFORMATION PROVIDED, IT WAS A NATURAL DISEASE PROGRESSION THAT WAS BEYOND THE DEVICE'S CONTROL. ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION TO TREAT THE DISEASE PROGRESSION. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS DEPLOYED TO EXTEND THE DEVICE DISTALLY. AS AN ACCOMPANYING OF THE PROCEDURE OF DEVICE DEPLOYMENT, A COIL EMBOLIZATION IN THE ANEURYSM SAC WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9566922 ↗

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