GORE TAG Conformable Thoracic Endoprosthesis TGU313110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132618033), received between Aug 7, 2018 and Jun 1, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Activation Failure” (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.

• InjuryJun 1, 2022Material Separation; Activation Failure; Material Separation; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR ACUTE TYPE A DISSECTION USING A 31MM X 31MM X 10CM CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG). THE CTAG WAS ADVANCED THROUGH 0.035 BOSTON SUPER STIFF WIRE TO DESCENDING AORTA. THE PHYSICIAN DIDN'T FEEL RESISTANCE WHEN PULLING DEPLOYMENT LINE DURING DEPLOYMENT. AFTER HE THOUGHT THAT THE DEPLOYMENT LINE WAS FULLY PULLED OUT, HE TRIED TO REMOVE THE DELIVERY CATHETER. HOWEVER, THE DELIVERY CATHETER COULDN'T BE REMOVED. THEN IT WAS FOUND THAT THE CTAG WAS PARTIALLY EXPANDED BY X-RAY EXAMINATION. THE DEPLOYMENT LINE WAS BROKEN WHEN DISTAL END OF STENT WAS DEPLOYED AND PROXIMAL PART WAS CONSTRAINED. THE PHYSICIAN USED KELLY DEVICE TO SHRINK THE PARTIAL EXPANDED CTAG TO PULL IT OUT. ANOTHER CTAG WAS USED TO COMPLETE PROCEDURE. THE PROCEDURE WAS PROLONGED FOR ABOUT 30MINS TO REMOVE THE CTAG. THE PATIENT TOLERATED THE PROCEDURE AND HAD MINOR ISCHEMIA BOWEL SYNDROME WITHIN THREE DAYS AFTER PROCEDURE. HE HAS RECOVERED NOW.

  Patient problems: Ischemia

  MAUDE report 14570840 ↗
• InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS TO TREAT A THORACIC AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2018, WITH CHIEF COMPLAINT OF INCREASING SHORTNESS OF BREATH AND A COUGH. A COMPUTED TOMOGRAPHY TAKEN REVEALED A POSSIBLE MYCOTIC ANEURYSM (SURROUNDING THE STENT GRAFT THERE IS INCREASING AMORPHOUS LOW DENSITY WITH TINY GAS BUBBLES, OVERALL PATTERN SUGGESTS POSSIBLE GRAFT INFECTION). IN ADDITION A SACCULAR ANEURYSM WAS PRESENT IN THE MID DESCENDING THORACIC AORTA JUST AT THE SUPERIOR MARGIN OF A PREVIOUSLY PLACED THORACIC AORTIC STENT GRAFT. IT WAS REPORTED THERE IS A POSSIBLE THORACIC GRAFT INFECTION AND/OR AORTA PLEURAL FISTULA. SUPERIOR TO THE THORACOABDOMINAL GRAFT THERE MAY BE A SACCULAR ANEURYSM. REPORTEDLY ON (B)(6) 2018, A REINTERVENTION OCCURRED. THE PHYSICIAN DID NOT FIND AN INFECTION AND TREATED THE SACCULAR ANEURYSM BY IMPLANTING AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS TO COVER THE SACCULAR ANEURYSM. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 7760469 ↗

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