GORE TAG Conformable Thoracic Stent Graft TGM212110Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132646890), received between Nov 18, 2021 and Apr 1, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED FROM THE AAA 24-01 TAMBE POST APPROVAL STUDY AND INFORMATION WAS OBTAINED FROM THE IMEDIDATA CLINICAL DATABASE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) DEVICES AND A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE THORACIC AORTA WAS COVERED FROM ZONES 2-5, WITH A TBE SIDE BRANCH BEING PLACED IN THE LEFT SUBCLAVIAN. ON (B)(6) 2026, A PATIENT WAS TREATED FOR A SECONDARY INTERVENTION ON A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM OF COMPONENTS, INCLUDING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) DEVICE PLACED DISTALLY TO THE TAMBE. ALL DEVICES WERE NAVIGATED INTO POSITION AND DEPLOYED SUCCESSFULLY. ON (B)(6) 2026, SPINAL CORD ISCHEMIA WAS OBSERVED. THIS EVENT IS LISTED AS PROCEDURE RELATED. THE ISCHEMIA WAS TREATED WITH A SPINAL DRAIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO INPATIENT REHAB ON (B)(6) 2026. ON (B)(6) 2026, A SPINAL CORD ISCHEMIA SCALE ASSESSMENT GRADED THE PATIENT AS 3C - NONAMBULATORY (WHEELCHAIR BOUN

  Patient problems: Ischemia

  MAUDE report 24756212 ↗
• InjuryDec 10, 2025Migration; Device Endoleak; Migration; Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ACUTE TYPE B DISSECTION UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED DUE TO THE DEVICE MIGRATING DISTALLY (4CM) AND CAUSING A TYPE 1A ENDOLEAK WITH ANEURYSMAL DEGENERATION. IT WAS RESOLVED BY IMPLANTING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE).

  Patient problems: Clinical Endoleak

  MAUDE report 23769045 ↗
• InjuryDec 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION IN ZONE 3 LSA UTILIZING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2023 THE PATIENT IS SCHEDULED TO UNDERGO A REINTERVENTION ON A PRIOR GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM GRAFT AS THE PHYSICIAN PLANS TO DO AN ANGIOGRAM AND MAKE A DECISION IF A REINTERVENTION IS TO TAKE PLACE AND IF TO EXTEND THE GRAFT PROXIMALLY DUE TO THE DISEASE PROGRESSION. IT IS CURRENTLY UNKNOWN ABOUT THE DETAILS OF THE DISEASE PROGRESSION. REPORTEDLY, THE FIELD SALES ASSOCIATE WAS NOTIFIED ABOUT A POSSIBLE SCHEDULED REINTERVENTION TO TAKE PLACE BY THE PHYSICIAN ON DECEMBER 04, 2023. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 14, 2023 REINTERVENTION: PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE DUE TO DISEASE PROGRESSION AND DISTAL DEVICE MOVEMENT OF THE CTAGAC (DISTANCE UNKNOWN) UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (SIDE BRANCH, AORTIC BRANCH COMPONENT AND BRANCH AORTIC EXTENDER). PHYSICIAN EXTENDED PROXIMALLY WITH THE DEVICES FROM THE ORIGINAL CTAGAC (UNKNOWN WHICH OF THE 2 CTAGAC WAS MORE PROX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376370 ↗
• MalfunctionDec 1, 2022Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  ON (B)(6) 2022, THE PATIENT WAS TREATED FOR AN ISSUE WITH ANOTHER MANUFACTURERS DEVICE. A UNILATERAL APPROACH UTILIZING AN 18FR SHEATH WAS PERFORMED. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS INSERTED IN A SHEATH ALONG WITH A PIGTAIL CATHETER. WHILE ATTEMPTING TO REMOVE THE PIGTAIL CATHETER FROM THE SHEATH, THE TIP OF THE DELIVERY CATHETER POPPED OFF IN THE VALVE OF THE SHEATH. A LARGER SHEATH WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE FSA BELIEVES THAT THE SHEATH WAS TOO SMALL TO ACCOMMODATE BOTH THE DEVICE AND THE PIGTAIL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894156 ↗
• InjuryNov 18, 2021Separation Failure; Separation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT PRESENTED WITH AN ANEURYSM IN THE THORACIC AORTA AND UNDERWENT TREATMENT UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE PHYSICIAN ADVANCED THE CTAG A/C DEVICE TO THE LEVEL OF THE LEFT SUBCLAVIAN ARTERY AND DEPLOYED THE GRAFT SUCCESSFULLY. UPON ATTEMPTED REMOVAL OF THE DELIVERY CATHETER, IT WAS OBSERVED THAT THE OLIVE TIP WAS CAUGHT ON A STENT STRUT. AFTER MULTIPLE ENDOVASCULAR ATTEMPTS TO DISLODGE THE OLIVE TIP, THE STENT STARTED TO PULL AWAY FROM THE GRAFT. THE GRAFT WAS ULTIMATELY PULLED DOWN INTO THE INFRARENAL AORTA AND THEN EXPLANTED SURGICALLY. ONCE THE GRAFT WAS EXPLANTED AND THE AORTA REPAIRED ANOTHER CTAG A/C DEVICE WAS DEPLOYED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12837211 ↗

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-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