GORE TAG Thoracic Endoprosthesis TGT3420Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132613656), received between Jan 11, 2019 and Nov 28, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR THORACIC AORTIC ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESES. ON AN UNKNOWN DATE, A REINTERVENTION WAS PERFORMED FOR UNKNOWN INDICATION AT ANOTHER HOSPITAL. AN ADDITIONAL GORE STENT GRAFT WAS PLACED DISTAL TO THE PREVIOUS DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 23669777 ↗
• InjuryMar 24, 2025Material Puncture/Hole; Material Puncture/Hole

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN THORACOABDOMINAL AORTIC ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESIS(CTAG). REPORTEDLY, TWO CTAG DEVICES WERE PLACED. ON (B)(6) 2025, A TYPE IIIB ENDOLEAK WAS OBSERVED ON THE COMPUTED TOMOGRAPHY(CT) IMAGING. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED, TWO ADDITIONAL STENT GRAFT WAS PLACED, THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IT SEEMS LIKE THE EDGE SIDE OF THE CTAG THAT WAS IMPLANTED DISTALLY WAS STICKING INTO THE ANOTHER CTAG THAT WAS IMPLANTED PROXIMALLY, THAT MIGHT HAVE CAUSED ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 21684671 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT UNDERWENT TREATMENT FOR A DESCENDING AORTIC ANEURYSM USING THE OPEN STENT TECHNIQUE WITH THE GORE® TAG® THORACIC ENDOPROSTHESIS. ON AN UNKNOWN DATE, DURING FOLLOW-UP, CONTRAST ENHANCEMENT REVEALED A SUSPECTED TYPE IIIB ENDOLEAK. ON (B)(6) 2025, THE PATIENT UNDERWENT INTERVENTION. INTRAOPERATIVE IMAGING DID NOT IDENTIFY A CLEAR ENDOLEAK. AN ADDITIONAL STENT GRAFT WAS PLACED TO RELINE THE EXISTING ONE. THE PHYSICIAN STATED AS FOLLOWS: THE INTRAOPERATIVE IMAGING DID NOT REVEAL A CLEAR ENDOLEAK. IF A LEAK IS DETECTED IN FUTURE FOLLOW-UP CT SCANS, THE POSSIBILITY OF A TYPE II ENDOLEAK WILL BE CONSIDERED.

  Patient problems: Insufficient Information

  MAUDE report 21628368 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE. ON UNKNOWN DATE, TOTAL ARCH REPLACEMENT WAS PERFORMED USING A SURGICAL GRAFT. ON (B)(6) 2011, THE PATIENT UNDERWENT TREATMENT OF THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (PROXIMAL-TGT3115/9042283, DISTAL-TGT3420/9077511). THE PROXIMAL END OF THE TGT3115 WAS PLACED IN THE DISTAL ANASTOMOSIS OF THE SURGICAL GRAFT. THE PROCEDURE WAS FINISHED WITH NO EVIDENCE OF ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON UNKNOWN DATE, IT WAS CONFIRMED THAT THE TGT3115 MIGRATED DISTALLY. THERE WAS AN UNKNOWN LEAK BETWEEN THE DISTAL ANASTOMOSIS AND THE TGT3115. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED IN ORDER TO DETERMINE THE ORIGIN OF THE LEAK, BUT IT WAS UNABLE TO DETERMINE THE EXACT ORIGIN OF THE LEAK. THE PHYSICIAN REPORTEDLY STATED THAT THE EXACT CAUSE OF THE LEAK WAS UNKNOWN. THE FLARE (THE PROXIMAL END) OF THE TGT3115 MIGHT HAVE CAUSED A DAMAGE TO THE SURGICAL GRAFT AND IT RESULTED IN A LEAK FROM THE SURGICAL GRAFT. ON (B)(6) 2018, THE PATIENT UNDERWENT SECONDARY INTERVENTION FOR TREATMENT OF UNKNOWN LEAK. A CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESIS (TGU343420J) WAS IMPLANTED COVERING THE DISTAL ANASTOMOSIS OF THE

  Patient problems: Aneurysm expansion

  MAUDE report 17105041 ↗
• InjuryNov 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES WITH AN ELEPHANT TRUNK TECHNIQUE AFTER A TOTAL ARCH REPLACEMENT AND AN ELEPHANT TRUNK THAT WERE PERFORMED ON AUGUST 16, 2013. DURING THE TREATMENT, AFTER ALL STENT GRAFTS WERE IMPLANTED, A POSSIBLE DISTAL TYPE I ENDOLEAK OR A POSSIBLE TYPE II ENDOLEAK WAS OBSERVED. ADDITIONALLY TOUCH UP WAS PERFORMED AT THE DISTAL SIDE OF THE DISTAL STENT GRAFT. THE PATIENT TOLERATED THE PROCEDURE. ON UNKNOWN DATE, AN ENLARGEMENT OF THE ANEURYSM WAS OBSERVED. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED. DURING THE REINTERVENTION, AN ANGIOGRAPHY REVEALED NO LEAK. ADDITIONALLY, A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED TO EXTEND PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT HE THOUGHT THAT INTRAOPERATIVE ANGIOGRAPHY WOULD REVEAL A LEAK THAT WAS CAUSING THE ANEURYSMAL ENLARGEMENT. AN ADDITIONAL STENT GRAFT WAS IMPLANTED TO COVER THE ANASTOMOSIS SITE. REPORTEDLY, THERE WERE TWO TAG DEVICES THAT WERE IMPLANTED, BUT IT WAS UNKNOWN WHICH DEVICE WAS IM

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 15801360 ↗
• InjuryMar 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH A GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2022, FOLLOW-UP IMAGING DETERMINED A DISTAL TYPE I ENDOLEAK, NO ANEURYSM ENLARGEMENT WAS REPORTED. THERE IS CURRENTLY NO TREATMENT PLAN IN PLACE FOR THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 13699635 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROBLEM ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM.

  Patient problems: Vascular Dissection

  MAUDE report 8376512 ↗
• InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THIS PATIENT UNDERWENT A STAGED PROCEDURE FOR TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM. VASCULAR GRAFTS WERE USED TO BYPASS TO THE CELIAC ARTERY, THE SUPERIOR MESENTERIC ARTERY AND THE BILATERAL RENAL ARTERIES AND MAINTAIN BLOOD FLOW. A GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, A SECOND STAGED PROCEDURE WAS PERFORMED AND THREE ADDITIONAL GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PARAPARESIS. FURTHER INTERVENTION WAS NOT PERFORMED. ON (B)(6) 2010, AT THE SIX MONTH FOLLOW UP FOR THE STUDY, THE PATIENT'S PARAPARESIS PERSISTED. ON (B)(6) 2011, AT THE ONE YEAR FOLLOW UP FOR THE STUDY, THE PATIENT'S PARAPARESIS PERSISTED. ON (B)(6) 2012, THE PATIENT WENT INTO CARDIOPULMONARY ARREST IN HIS HOME. THE PATIENT WAS EMERGENTLY ADMITTED TO THE HOSPITAL WHEREIN HE EXPIRED LATER THIS SAME DAY.

  Patient problems: Aneurysm

  MAUDE report 8348780 ↗
• InjuryJan 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM AND TWO GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED. INTRAOPERATIVELY, A TYPE III ENDOLEAK FROM THE OVERLAP JUNCTION OF THE TWO DEVICES WAS OBSERVED. NO ADDITIONAL TREATMENT WAS PERFORMED AS THE LEAK WAS THOUGHT TO BE A DELAY LEAK. ON (B)(6) 2016, THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER® AAA ENDOPROSTHESES, WITH PLACEMENT OF A NON-GORE BARE METAL STENT WITHIN THE LEFT EXTERNAL ILIAC ARTERY. ADDITIONALLY, BYPASS OF THE LEFT INTERNAL ILIAC ARTERY AND THE LEFT EXTERNAL ILIAC ARTERY WAS PERFORMED. ON UNKNOWN DATE IN 2016, A NEW ANEURYSM WITHIN THE AORTIC ARCH WAS IDENTIFIED. ON (B)(6) 2016, THE PATIENT UNDERWENT REINTERVENTION AND AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED JUST DISTAL TO THE LEFT COMMON CAROTID ARTERY AND THE LEFT SUBCLAVIAN ARTERY WAS EMBOLIZED WITH VASCULAR PLUGS TO TREAT THE AORTIC ARCH ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK. ON UNKNOWN DATE, ENLARGEMENT (AMOUNT UNKNOWN) OF THE ARCH ANEURYSM WAS REPORTED TO BE CAUSED BY AN UNKNOWN TYPE OF EN

  Patient problems: Aneurysm

  MAUDE report 8241302 ↗
• InjuryJan 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM AND TWO GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED. INTRAOPERATIVELY, A TYPE III ENDOLEAK FROM THE OVERLAP JUNCTION OF THE TWO DEVICES WAS OBSERVED. NO ADDITIONAL TREATMENT WAS PERFORMED AS THE LEAK WAS THOUGHT TO BE A DELAY LEAK. ON (B)(6) 2016, THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER® AAA ENDOPROSTHESES, WITH PLACEMENT OF A NON-GORE BARE METAL STENT WITHIN THE LEFT EXTERNAL ILIAC ARTERY. ADDITIONALLY, BYPASS OF THE LEFT INTERNAL ILIAC ARTERY AND THE LEFT EXTERNAL ILIAC ARTERY WAS PERFORMED. ON UNKNOWN DATE IN 2016, A NEW ANEURYSM WITHIN THE AORTIC ARCH WAS IDENTIFIED. ON (B)(6) 2016, THE PATIENT UNDERWENT REINTERVENTION AND AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED JUST DISTAL TO THE LEFT COMMON CAROTID ARTERY AND THE LEFT SUBCLAVIAN ARTERY WAS EMBOLIZED WITH VASCULAR PLUGS TO TREAT THE AORTIC ARCH ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK. ON UNKNOWN DATE, ENLARGEMENT (AMOUNT UNKNOWN) OF THE ARCH ANEURYSM WAS REPORTED TO BE CAUSED BY AN UNKNOWN TYPE OF EN

  Patient problems: Aneurysm

  MAUDE report 8241261 ↗

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