GORE® Tri Lumen Catheter TLC140Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132644421), received between Jul 3, 2024 and Apr 27, 2026 — classified as 1 death, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Break

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT TAMBE ENDOVASCULAR TREATMENT FOR AN ARTERIAL DISSECTION UTILIZING MULTIPLE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES IN THE VISCERAL VESSELS AND A GORE® TRI-LUMEN CATHETER (TLC). A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED TO BE IMPLANTED IN THE LEFT RENAL ARTERY, HOWEVER, IT WAS LEFT IMPLANTED IN THE RIGHT INNOMINATE ARTERY. IT WAS REPORTED THE PHYSICIAN REACHED THE LEFT RENAL ARTERY AND PULLED THE DEPLOYMENT LINE ALL THE WAY. HOWEVER, THE PHYSICIAN HAD DIFFICULTY VISUALIZING IF THE VIABAHN ENDOPROSTHESIS EXPANDED PROPERLY UNDER FLUOROSCOPIC IMAGING. THE DELIVERY CATHETER WAS THEN WITHDRAWN AND IT WASN¿T UNTIL THE PHYSICIAN WAS AT THE RIGHT INNOMINATE ARTERY WHEN THEY NOTICED THE VIABAHN ENDOPROSTHESIS DID NOT DEPLOY IN THE LEFT RENAL ARTERY. WHEN BEING WITHDRAWN, THE VIABAHN DEVICE MET RESISTANCE BY GETTING CAUGHT ON AN UNSPECIFIED MATERIAL, CAUSING THE VIABAHN ENDOPROSTHESIS TO DISLODGE INTO THE RIGHT INNOMINATE ARTERY. THE VIABAHN ENDOPROSTHESIS DID NOT COVER ANY MAJOR BRANCH VESSELS, AND THE RIGHT INNOMINATE ARTERY STILL HAD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997950 ↗
• MalfunctionNov 21, 2025Break; Break

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TRI LUMEN CATHETER (TLC). IT WAS REPORTED THAT DURING THE PROCEDURE, THE GREY EXTENSION TUBE WAS BROKEN ON THE FIRST PASS. THE WIRE WAS FED DIRECTLY INTO THE CATHETER. A SECOND CATHETER WAS THEN OPENED AND USED FOR THE NEXT PASS. THERE WAS NO HARM TO THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622510 ↗
• InjuryNov 19, 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) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR PARARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE USED DEVICES OTHER THAN TAMBE ARE LISTED BELOW: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS: 6 COMPONENTS IN TOTAL. GORE® EXCLUDER® AAA ENDOPROSTHESIS: ONE CONTRALATERAL LEG. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE): ONE ILIAC BRANCH COMPONENT. GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). GORE® TRI LUMEN CATHETER. GORE® MOLDING & OCCLUSION BALLOON CATHETER. DURING THE PROCEDURE, INSERTION OF A 22FR DSF VIA THE LEFT FEMORAL ARTERY WAS ATTEMPTED BUT WAS DIFFICULT TO ADVANCE DUE TO CALCIFICATION. THE SHEATH WAS EXCHANGED FOR A 16FR DSF, BUT SIMILAR RESISTANCE WAS ENCOUNTERED. AFTER GUIDEWIRE EXCHANGE, BOTH 16FR AND 22FR DFSS WERE ADVANCED WITH RESISTANCE BUT SUCCESSFULLY INSERTED. WHILE POSITIONING THE AORTIC COMPONENT, WIRE WRAP OCCURRED AND WAS RESOLVED BY ROTATING THE GUIDEWIRE 360 DEGREES. THE AORTIC COMPONENT WAS DEPLOYED WITHOUT ISSUE. CANNULATION OF THE LEFT RENAL ARTERY WAS CHALLENGING, BUT AFTER GUIDEWIRE EXCHANGE, THE BRANCH COMPONENT

  Patient problems: Embolism/Embolus; Renal Impairment

  MAUDE report 23591297 ↗
• DeathJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) IN ZONE 5 WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE USED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. IT WAS REPORTED PRIOR TO THE PROCEDURE; THE PATIENT'S LEFT RENAL ARTERY WAS ALREADY OCCLUDED. DURING THE PROCEDURE, THERE WAS A DISTAL PERFORATION IN THE RIGHT RENAL DUE TO A 0.035" ROSEN GUIDEWIRE. THE PERFORATION WAS RESOLVED BY PLACEMENT OF A NON-GORE CORONARY COVERED STENT. THE PHYSICIAN HAD RIGHT SIDED ACCESS DUE TO THE LEFT SUBCLAVIAN BEING STENOTIC AND ALREADY HAVING AN UNKNOWN STENT IN PLACE FROM A PREVIOUS SURGERY. THE PHYSICIAN IMPLANTED ALL DEVICES WITHOUT ANY ISSUES. TWO VBX DEVICES WERE IMPLANTED IN THE SMA, THREE VBX DEVICES WERE IMPLANTED IN THE RIGHT RENAL, AND TWO VBX DEVICES WERE IMPLANTED IN THE CELIAC. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED THE PATIENT HAD A STROKE AND EXPIRED. THE PHYSICIAN STATED DISPLACEMENT OF ATHEROMA (PLAQUE) IN THE ARCH, M

  Patient problems: Ischemia Stroke

  MAUDE report 22175639 ↗
• MalfunctionMay 19, 2025Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TRI LUMEN CATHETER (TLC) IN ZONE 5. IT WAS REPORTED THAT THE TLC WAS FLUSHED PER IFU, LOADED ON THE WIRE AND THEY IMMEDIATELY FELT RESISTANCE WHEN INSERTING; HOWEVER, THEY DECIDED TO CONTINUE TO USE THE TLC. THEY PULLED OUT THE TLC DEVICE TO RELOAD IT AND NOTICED THAT THE GREY EXTENSION TUBE WAS DAMAGED. IT DID NOT BREAK BUT IT WAS DAMAGED (MANGLED). THE PHYSICIAN DECIDED TO USE A NEW TLC TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048641 ↗
• MalfunctionNov 13, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM USING A GORE® TRI-LUMEN CATHETER. AFTER INSERTING THE CATHETER, ONE OF THE SIDE PARTS OF THE CATHETER BROKE OFF. THE PHYSICIAN DID ONE PASS OF THE WIRE, AND THEN WITHDREW THE CATHETER AND REPLACED WITH ANOTHER. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674698 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT DURING IMPLANT OF THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT THE DEVICE WAS ALMOST COMPLETELY PULLED OUT OF THE 3CM OVERLAP ZONE DURING REMOVAL OF THE DEVICE DELIVERY SYSTEM. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WAS IMPLANTED TO BRIDGE ANY GAP AND RELINE THE AREA. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE USED AS BRANCH DEVICES IN THE SUPERIOR MESENTERIC ARTERY, CELIAC ARTERY, RIGHT AND LEFT RENAL ARTERIES. A GORE® TRI LUMEN CATHETER WAS USED TO GAIN THROUGH AND THROUGH WIRE ACCESS TO THE BRANCH ARTERIES. THE PROCEDURE WAS COMPLETED WITH GOOD TECHNICAL RESULTS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT AWOKE AND HAD NO FEELING IN HIS LEGS. THE PATIENT UNDERWENT PLACEMENT OF A SPINAL DRAIN. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE PARAPLEGIA. THE PATIENT IS BEING MONITORED IN THE INTENSIVE CARE UNIT (ICU) AND WAS REPORTED TO HAVE STARTED REGAINING MOVEMENT IN HIS RIGHT LEG AN

  Patient problems: Paraplegia

  MAUDE report 19671006 ↗