GORE VIABAHN Endoprosthesis with Heparin VBJR051002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132623914), received between Sep 11, 2019 and Jul 29, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50064114 ↗
• MalfunctionAug 29, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT PRESENTED FOR TREATMENT OF AN OCCLUDED FEMORO-POPLITEAL ARTERY. AS REPORTED, THE PATIENT HAD AN IMPLANT PROCEDURE USING THE PATIENT'S VEIN APPROXIMATELY FOUR MONTHS EARLIER. FROM THE LEFT COMMON FEMORAL ARTERY ACCESS SITE, A 6FR X 65CM TERUMO SHEATH WAS INSERTED UP AND OVER THE BIFURCATION TO THE OCCLUDED IMPLANT IN THE RIGHT LEG. OVER AN .014 X 300CM V14 GUIDE WIRE (BSC), A 5 X 15 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS IMPLANTED DISTALLY AND EXTENDED INTO THE IMPLANTED VEIN. AFTER DEVICE POST DILATION, THE PHYSICIAN OPTED TO IMPLANT ANOTHER VIABAHN® DEVICE (5 X 10) FOR FURTHER DISTAL EXTENSION. THE VIABAHN® DEVICE WAS PLACED AND DEPLOYMENT WAS STARTED WHEN THE LINE BROKE INSIDE THE CATHETER. THE PHYSICIAN WAS ABLE TO RETRACT THE CONSTRAINED VIABAHN® DEVICE THROUGH THE SHEATH WITH NO ISSUES. AN ADDITIONAL VIABAHN® DEVICE WAS IMPLANTED PROXIMAL TO THE 5 X 15 VIABAHN® DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22924673 ↗
• MalfunctionAug 4, 2022Break; Break

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), A PATIENT WAS UNDERGOING A PROCEDURE TO TREAT THE ILIAC ARTERY WITH THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. DURING THE PROCEDURE, THE DEVICE WAS PLACED ONTO A 0.018 MM GUIDEWIRE AND INSERTED INTO THE SHEATH. THE PHYSICIAN NOTED THAT IT APPEARED AS THOUGH THE DEVICE CAME OFF THE CATHETER AND DISTAL TIP CAME DETACHED. THE DEVICE, CATHETER AND DISTAL TIP WERE REMOVED FROM PATIENT. THE DISTAL TIP WAS DISCARDED AT THE FACILITY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15169947 ↗
• MalfunctionMay 11, 2021Break; Break

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021 A PHYSICIAN WAS ATTEMPTING TO RELINE A PREVIOUSLY IMPLANTED STENOSED BARE METAL STENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OF A PATIENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX) DEVICE. WHILE ATTEMPTING TO RELINE THE BARE METAL STENT (BMS) WITH THE VSX DEVICE, THE VSX DEVICE BECAME CAUGHT ON A STRUT OF THE BMS, CAUSING THE DEPLOYMENT LINE TO BREAK. THE DEVICE AND DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WITH NO ADVERSE OUTCOMES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805915 ↗
• InjuryOct 21, 2020Material Integrity Problem; Material Integrity Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT WAS BEING IMPLANTED FOR AN ANASTOMOSIS PROCEDURE IN THE SUPERIOR FEMORAL ARTERY TO EXTENDED DISTALLY FROM A PREVIOUSLY IMPLANTED DEVICE. DURING DEPLOYMENT IT WAS REPORTED THE STENT GRAFT PARTIALLY EXPANDED DUE TO THE DEPLOYMENT LINE BREAKING. THE PHYSICIAN STATED THE CAUSE OF THE DEPLOYMENT LINE BREAKING IS UNKNOWN. IT WAS REPORTED THE PATIENT WAS CONVERTED TO A SURGICAL CONVERSION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10712138 ↗
• MalfunctionMar 31, 2020Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR SFA OCCLUSION TREATMENT. THE PHYSICIAN CHOSE AN UP AND OVER APPROACH. USING A FLEXOR® RAABE GUIDING SHEATH AND A .035 GLIDEWIRE ADVANTAGE® GUIDEWIRE, THE GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED INTO PLACE MID-POPLITEAL. WHEN THE DEPLOYMENT LINE WAS PULLED, IT BROKE. THE DEVICE WAS PULLED BACK INTO THE SHEATH AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND GORE® VIABAHN® ENDOPROSTHESIS. THE DEVICE AND DEPLOYMENT LINE WERE GIVEN TO THE HOSPITAL RISK MANAGER.

  Patient problems: Occlusion

  MAUDE report 9904331 ↗
• MalfunctionMar 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED BY THE FSA: ON (B)(6) 2020 THE PATIENT PRESENTED OCCLUSION IN THE SUPERFICIAL ARTERY. WHEN DEPLOYING THE GORE® VIABAHN® ENDOPROSTHESIS THE DEPLOYMENT LINE CAME OUT AND THE PHYSICIAN COMMENTED THE DEPLOYMENT LINE 'LOOKED TORN'. THE FSA REPORTED THAT THE DOCTOR APPEARED TO AGGRESSIVELY PULL THE DEPLOYMENT LINE AND MAY HAVE CONTRIBUTED TO THE DEPLOYMENT LINE BREAK. WHEN THE PHYSICIAN WENT TO PULL THE CATHETER OUT OF THE PATIENT HE REALIZED THE STENT WAS NOT FULLY DEPLOYED AND HAD INADVERTENTLY PULLED THE GORE® VIABAHN® ENDOPROSTHESIS BACK THROUGH THE VESSEL AND INTO THE SHEATH. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE AND SHEATH IN TANDEM. A 5MM X 10CM GORE® VIABAHN® ENDOPROSTHESIS WAS SUCCESSFULLY DEPLOY TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9819328 ↗
• InjuryFeb 3, 2020Failure to Unfold or Unwrap; Difficult or Delayed Activation; Failure to Unfold or Unwrap; Difficult or Delayed Activation

  THE FOLLOWING INFORMATION WAS PROVIDED TO GORE: THE PATIENT PRESENTED WITH CTO IN THE RIGHT SFA/PROXIMAL POPLITEAL. THE PHYSICIAN GAINED ACCESS THROUGH THE LEFT GROIN AND PERFORMED UP AND OVER APPROACH WITH 6 FR, 45 CM LONG SHEATH. ADDITIONALLY, THE PHYSICIAN GAINED PEDAL ACCESS AND ESTABLISHED A THROUGH AND THROUGH WIRE. HE THEN PRE-DILATED THE LESION WITH A 5MM BALLOON, STATING THE PRE-DILATION LOOKED GOOD. THE DOCTOR ALLEGED HE EXPERIENCED DIFFICULTY DEPLOYING THE GORE® VIABAHN® ENDOPROSTHESIS AND USED THE 2ND ACCESS POINT (PEDAL) TO BALLOON ASSIST THE EXPANSION OF THE DEVICE TO REMOVE OF THE CATHETER. THE DOCTOR ALSO REPORTED THAT DURING THE BALLOON INFLATE/PULL PROCESS, THE GORE® VIABAHN® ENDOPROSTHESIS MOVED INTO THE ILIAC ARTERY PARTIALLY COVERING THE HYPOGASTRIC ARTERY AND THE PROFUNDA ARTERY. AT THE COMPLETION OF THE PROCEDURE, THE PHYSICIAN CONFIRMED FLOW INTO THE INTERNAL ILIAC AND THE PROFUNDA. THE PATIENT IS REPORTED TO BE FINE.

  Patient problems: Occlusion

  MAUDE report 9661139 ↗
• MalfunctionOct 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: THE HOSPITAL REPORTED THAT A GORE® VIABAHN® ENDOPROSTHESIS DEPLOYMENT LINE BROKE DURING DEPLOYMENT.

  Patient problems: No Information

  MAUDE report 9180580 ↗
• MalfunctionOct 10, 2019Activation Problem; Activation Problem

  THE FOLLOWING WAS REPORTED TO GORE: WHEN THE DEPLOYMENT LINE OF THE GORE® VIABAHN® ENDOPROSTHESIS WAS PULLED, NOTHING HAPPENED. ANOTHER GORE® VIABAHN® ENDOPROSTHESIS WAS SUCCESSFULLY USED TO COMPLETE THE CASE.

  Patient problems: Occlusion

  MAUDE report 9177182 ↗
• InjurySep 11, 2019Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED TO GORE BY THE HOSPITAL: THE DOCTOR PLACED A GORE® VIABAHN® ENDOPROSTHESIS IN A PATIENT'S POPLITEAL ARTERY. WHILE IT WAS BEING DEPLOYED THE DEPLOYMENT LINE BROKE (IT WASN'T DEPLOYED ALL THE WAY). THE DOCTOR WAS ALREADY IN THE OR AND WAS ABLE TO REMOVE THE DEVICE SURGICALLY.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 8993137 ↗