GORE Tri-Lobe Balloon Catheter BCL2645Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132605224), received between Nov 15, 2019 and Apr 2, 2026 — classified as 2 deaths, 6 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS) USING A GORE®¿DRYSEAL FLEX INTRODUCER SHEATH AND A GORE® TRI-LOBE BALLOON CATHETER TO TREAT AN ASCENDING THORACIC DISSECTION. REPORTEDLY DURING THE PROCEDURE WHILE RETRACTING THE DELIVERY CATHETER OF THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER THE DEVICE MOVED DISTALLY AND PARTIALLY COVERED THE INNOMINATE ARTERY. THE PHYSICIAN IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN THE INNOMINATE ARTERY TO MAINTAIN PATENCY. THEN THE PHYSICIAN IMPLANTED A SECOND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE. POST PROCEDURE IMAGES REVEALED A TYPE B DISSECTION FROM IMPLANTED GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER EXTENDING DOWN INTO THE ILIAC ARTERY. THE PHYSICIAN IS NOT TREATING THE DISSECTION AT THIS TIME. THE EVENT IS ONGOING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 24770695 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR PROCEDURE TO TREAT A PENETRATING ATHEROSCLEROTIC (PAU) UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND GORE® TRI-LOBE BALLOON CATHETER. IT WAS REPORTED A TBE AORTIC EXTENDER WAS IMPLANTED AT THE PROXIMAL EDGE OF THE TBE AORTIC COMPONENT. UPON PHYSICIAN BALLOONING THE OVERLAP BETWEEN THE TBE AORTIC COMPONENT AND TBE AORTIC EXTENDER, A LITTLE BIT OF WASTE WAS NOTED ON THE LESSER CURVE OF THE AORTA AND APPEARED TO POP OUT. ALLEGEDLY, THE BALLOON WAS NOTED TO BE FULLY INSIDE THE GRAFT, HOWEVER THE BALLOONING APPEARED TO RUPTURE THE ASCENDING AORTA. IT WAS ALSO REPORTED THE PATIENT CODED AFTER THE BALLOONING WAS PERFORMED, AND WAS CONVERTED TO OPEN HEART REPAIR. THE PATIENT IS ALIVE AND IS ON BYPASS. PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS ISSUE, AS NO EXCESSIVE FORCE WAS USED FOR BALLOONING. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 24639195 ↗
• DeathMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WITH A GORE® TRI-LOBE BALLOON CATHETER TO TREAT A THORACIC DISSECTION WITH AN INTRAMURAL HEMATOMA PRESENT. IT WAS REPORTED THAT AFTER DEPLOYING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR313110/(B)(6), IMAGES REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN CHOSE TO USE A GORE® TRI-LOBE BALLOON CATHETER TO BALLOON THE ENDOLEAK. REPORTEDLY THE PHYSICIAN WAS ¿AGGRESSIVELY¿ BALLOONING THE PROXIMAL ENDOLEAK AND PERFORATED THE AORTA. WHILE RETRACTING THE BALLOON THE PATIENT CODED. THE PHYSICIAN IMPLANTED AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR313110/(B)(6) TO TREAT THE PERFORATED AORTA. A BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT NEVER RECOVERED FROM THE CODE AND EXPIRED IN THE OPERATING ROOM. REPORTEDLY THE PATIENT HAD A FRIABLE AORTA WITH HISTORY OF CARDIAC ISSUES AND PERIPHERAL VASCULAR DISEASE. DURING THE CODE THE PATIENT DEVELOPED A PLEURAL EFFUSION FROM THE BLEEDING.

  Patient problems: Vascular Dissection

  MAUDE report 21703660 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM AND A GORE® TRI-LOBE BALLOON CATHETER. IT WAS REPORTED THAT THERE WERE NO ISSUES DURING DEVICE PLACEMENT, AND THE PROXIMAL TGMR373715 WAS IMPLANTED JUST DISTAL TO THE PATIENT'S LEFT SUBCLAVIAN ARTERY ORIGIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED ISSUES AND THE PATIENT WAS DOING WELL POST OPERATIVELY. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED ACUTE LEFT LEG WEAKNESS. A SPINAL DRAIN WAS PLACED AND THE PATIENT WAS ADMITTED TO THE ICU FOR MONITORING. THE SUSPECTED CAUSE OF THE LEFT LEG WEAKNESS REPORTEDLY REMAINS UNKNOWN. NO PATIENT ANATOMY WAS SUSPECTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT CONTINUES TO BE MONITORED.

  Patient problems: Paresis

  MAUDE report 19945251 ↗
• DeathJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A THORACIC ANEURYSM UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AND GORE® TRI-LOBE BALLOON CATHETER. UPON ATTEMPTING TO BALLOON THE PROXIMAL END OF TAC123715A DEVICE, THE PATIENT'S AORTA RUPTURED. MEDICAL STAFF ATTEMPTED CPR ON THE PATIENT FOR 10 MINUTES, AND ULTIMATELY PATIENT COULD NOT BE REVIVED AND EXPIRED. IT WAS ALSO REPORTED THERE WERE NO ISSUES DURING THE PROCEDURE, WHILE IMPLANTING THE DEVICES. THE BALLOON DID NOT RUPTURE AND WAS NOT OVER INFLATED. IN ADDITION, NO CALCIFICATION WAS NOTED. PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS ISSUE. PHYSICIAN ALSO REPORTS AS PATIENT WAS OLDER, PATIENT PRESENTED WITH A FRAGILE AORTA. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 19638821 ↗
• InjuryDec 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC). THE CTAG-AC WAS THE MOST PROXIMAL DEVICE AND WAS DEPLOYED JUST DISTAL TO THE LOWEST RENAL ARTERY WITH THE EXCLUDER TRUNK HAVING BEEN DEPLOYED WITHIN THE CTAG-AC DUE TO THE SIZE OF THE PATIENT AORTA AND THE SIZE OF THE ANEURYSM (7CM). POST DEPLOYMENT OF ALL DEVICES AND ANGIOPLASTY OF ALL THE DEVICES A SMALL PROXIMAL TYPE I ENDOLEAK WAS NOTED. A SECOND BALLOON INFLATION WITH A GORE® TRI-LOBE BALLOON CATHETER (BCL2645/26440564) ENSUED WITH THE TRI-LOBE BALLOON CATHETER UPON WHICH THE PROXIMAL AORTA WAS NOTICED TO HAVE RUPTURED. THE PATIENT WAS CONVERTED TO OPEN WHEREIN ALL THE DEVICES WERE EXPLANTED AND A DACRON GRAFT WAS SEWN INTO THE AORTA. THE PATIENT TOLERATED THE PROCEDURE. THE RUPTURE IS BELIEVED TO HAVE BEEN DUE TO OVERINFLATION OF THE BALLOON DURING ANGIOPLASTY. THE EXPLANTED DEVICES WERE DISCARDED AT THE SITE.

  Patient problems: Rupture

  MAUDE report 18270481 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT EMERGENCY TREATMENT OF A SYMPTOMATIC ZONE 0 DISSECTING ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH AND A GORE® TRI-LOBE BALLOON CATHETER WERE USED AS ACCESSORIES IN THE PROCEDURE. THE PATIENT'S ANATOMY WAS REPORTED TO BE EXTENSIVELY TORTUOUS. ON (B)(6) 2022, THE GORE REPRESENTATIVE WAS MADE AWARE THAT THE PATIENT HAD SPINAL CORD ISCHEMIA WHICH WAS OBSERVED ON THE EVENING OF THE INDEX PROCEDURE. IT WAS REPORTED THAT A NON-PROPHYLACTIC SPINAL DRAIN WAS PLACED POST-PROCEDURE AND A PLAN WAS MADE TO DISCHARGE THE PATIENT TO A REHAB CENTER. THE SPINAL CORD ISCHEMIA IS ONGOING. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS ARE IMPROVING.

  Patient problems: Ischemia

  MAUDE report 15592779 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEMS (TGMR373715/20930111) WHILE UTILIZING A GORE® TRI-LOBE BALLOON CATHETER (BCL2645/18292403). IT WAS REPORTED THE PATIENTS DESCENDING THORACIC AORTA RUPTURED WHEN BALLOONED AT THE DISTAL DEVICE. WE EXTENDED THE RUPTURED AREA WITH ANOTHER 37X15 DEVICE. ALL SUBSEQUENT AORTA GRAMS SHOWED NO LEAK, HOWEVER, PATIENT¿S PRESSURE IS STILL BEING ACTIVELY MANAGED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9331903 ↗