GORE VIABAHN Endoprosthesis with Heparin VBHR081502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132623150), received between Oct 31, 2023 and Nov 4, 2025 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON AN UNKNOWN DATE, TWO 8MM GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICES) WERE IMPLANTED IN THE POPLITEAL ARTERY DURING TREATMENT OF AN ANEURYSM. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION ON THE PREVIOUSLY PLACED DISTAL VSX DEVICE THAT MIGRATED UP INTO THE ANEURYSMAL SAC. THE PHYSICIAN GAINED CONTRALATERAL ACCESS AN 8F COOK ANSEL INTRODUCER SHEATH OVER AN 0.035' AMPLATZ GUIDE WIRE. REPORTEDLY, DURING THE ADVANCEMENT THOUGH THE EXTREMELY TORTUOUS ANATOMY, THE PHYSICIAN FELT RESISTANCE AND WASN'T ABLE TO FULLY CROSS THE LESION. HOWEVER, DURING THE REMOVAL OF THE DELIVERY CATHETER THE DISTAL PORTION OF THE CATHETER DETACHED AND REMAINED ON THE WIRE. THE PHYSICIAN REMOVED THE SHEATH, WIRE AND DETACHED CATHETER IN TANDEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ADDITIONAL 7 MM X 25 CM AND 8 MM X 15 CM VSX DEVICES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465300 ↗
• DeathJun 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR AORTOILIAC OCCLUSIVE DISEASE IN THE DISTAL AORTA, BILATERAL COMMON AND EXTERNAL ILIAC ARTERIES. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN BEGAN WITH FEMORAL ENDARTERECTOMY OF THE COMMON FEMORAL ARTERIES. AFTER COMPLETION OF THE ENDARTERECTOMY, BILATERAL ACCESS WAS GAINED AND CORDIS 8 FR BRITE TIP® INTRODUCER SHEATHS WERE INSERTED. THE LESIONS WERE CROSSED; HOWEVER, THE PHYSICIAN ENCOUNTERED A SUBINTIMAL POSITION AT THE DISTAL AORTA. INITIALLY, A COOK MEDICAL BEBACK CROSSING CATHETER WAS ATTEMPTED TO BE USED. A PHILIPS PIONEER PLUS IVUS-GUIDED CATHETER WAS SELECTED FOR RE-ENTRY INTO THE DISTAL AORTA. TWO 8X79 VBX DEVICES WERE DEPLOYED BILATERALLY INTO THE DISTAL AORTA AND COMMON ILIAC ARTERIES USING A KISSING STENT TECHNIQUE. TO EXCLUDE THE AORTIC DISEASE, THE VBX DEVICES WERE SLIGHTLY RAISED IN THE BIFURCATION. TO PRESERVE THE HYPOGASTRIC ARTERY, AN 8X60 BOSTON SCIENTIFIC INNOVA¿ VASCULAR SELF-EXPANDING STENT SYSTEM (INNOVA STENT) WAS DEPLOYED INTO THE 8X79 VBX DEVICE THAT WAS IMPLANTED ON THE RIGHT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 22216148 ↗
• MalfunctionNov 27, 2024Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN ETIOLOGY IN AN UNKNOWN ANATOMICAL LOCATION WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS IMPLANTED. IT WAS REPORTED THE PHYSICIAN REACHED THE TARGET TREATMENT AREA AND INITIATED DEPLOYMENT OF THE VIABAHN DEVICE WHEN THE DEPLOYMENT LINE BROKE. THE PHYSICIAN WAS ABLE TO DEPLOY THE VIABAHN DEVICE BY USING HEMOSTATS AND GRABBING THE DEPLOYMENT LINE THAT WAS IN THE VIABAHN HUB AND DEPLOYING THE DEVICE SUCCESSFULLY. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798578 ↗
• InjuryOct 31, 2023Difficult to Remove; Difficult to Remove

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT TREATMENT OF TWO ANEURYSMS, ONE IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY AND ONE IN THE POPLITEAL ARTERY. AN 8MM X 15CM GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE POPLITEAL ARTERY. THE PHYSICIAN SUCCESSFULLY CROSSED BOTH ANEURYSMS WITH A STIFF GLIDEWIRE®. THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN) WAS PARKED JUST BEFORE A TORTUOUS BEND IN THE RIGHT EXTERNAL ARTERY. THE LANDING ZONE FOR THE FIRST VSX DEVICE WAS JUST BEYOND A SHARP TORTUOUS BEND IN THE POPLITEAL ARTERY. THE PHYSICIAN WAS UNABLE TO ADVANCE THE VSX DEVICE PAST THE SHARP BEND IN THE POPLITEAL ARTERY. AS THE PHYSICIAN WAS REMOVING THE VSX DEVICE, IT GOT HUNG UP ON THE OUTER EDGE OF THE SHEATH. SINCE THE VSX DEVICE WOULDN¿T GO INTO THE SHEATH, SHE DECIDED TO REMOVE THE SHEATH AND VSX DEVICE IN TANDEM. THE SHEATH CAME OUT HOWEVER THE VSX DEVICE WOULD NOT FIT THROUGH THE ARTERIOTOMY IN THE LEFT COMMON FEMORAL ARTERY. SHE THEN PROCEEDED TO DUE A CUT DOWN IN ORDER TO REMOVE THE VSX DEVICE FROM THE ARTERIOTOMY IN THE LEFT COMMON FEMORAL ARTERY. AFTER THE INTRODUCER SHEATH, VSX DEVICE AND GUIDE WIRE WERE REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041648 ↗