GORE VIABAHN Endoprosthesis with Heparin VBJR052502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132623938), received between Nov 29, 2018 and May 21, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Activation Failure

  ON (B)(6) 2026, THE PATIENT UNDERWENT TREATMENT FOR AN ANEURYSM WITH STENOSIS IN THE UPPER REGION OF AN EXISTING RIGHT FEMORAL-POPLITEAL BYPASS GRAFT (UNKNOWN MANUFACTURE) USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE). IT WAS REPORTED THE LESION WAS PRE-DILATED AND THE DELIVERY CATHETER ADVANCED TO THE TARGET TREATMENT SITE THROUGH A 7F TERUMO PINNACLE® DESTINATION® GUIDING SHEATH OVER A .035" TERUMO GLIDEWIRE ADVANTAGE GUIDEWIRE SUCCESSFULLY. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE ENDOPROSTHESIS, IT WAS REPORTED ONE-THIRD OF THE DEPLOYMENT LINE WAS PULLED, WHEN BOWSTRINGING WAS OBSERVED AND DEPLOYMENT WAS CEASED. THE PHYSICIAN THEN WITHDREW THE DELIVERY CATHETER THROUGH THE SHEATH WITH NO DELIVERY CATHETER DAMAGE OR ENDOPROSTHESIS DISTAL EXPANSION NOTICED. IT WAS REPORTED THE VIABAHN DEVICE WAS DEPLOYED SUCCESSFULLY ON THE BACK TABLE AND DISCARDED. TO COMPLETE THE PROCEDURE, IT WAS REPORTED A NEW DEVICE WAS SELECTED, ADVANCED AND DEPLOYED WITHOUT INCIDENT. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244628 ↗
• MalfunctionFeb 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A 5MM X 25CM GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS PLACED AS A POST TERRIER TIBIAL VEIN/ARTERY FISTULA. WITH A V18 GUIDE WIRE THE PHYSICIAN HAD THROUGH AND THROUGH WIRE ACCESS, THROUGH A 7FR TERUMO INTRODUCER SHEATH. AFTER THE VSX DEVICE WAS SUCCESSFULLY DELIVERED, THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY CATHETER. HOWEVER, THE PHYSICIAN FELT RESISTANCE AND CONTINUED TO PULL THE DELIVERY CATHETER. UPON REMOVAL OF THE DELIVERY CATHETER FORM THE PATIENT, IT WAS NOTICED THAT THE DISTAL TIP WAS MISSING. WITH THROUGH AND THROUGH WIRE ACCESS THE PHYSICIAN USED AND UNINFLATED BALLOON TO PUSH THE DISTAL TIP OUT OF THE PATIENT. OTHER - APPLICATION AND ANATOMICAL LOCATION, POST TERRIER TIBIAL VEIN/ARTERY FISTULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636122 ↗
• InjuryJan 17, 2024Separation Failure; Activation Failure; Separation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A 5MM X 25CM GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE DISTAL SUPERFICIAL FEMORAL ARTERY DURING TREATMENT OF IN STENT RE-STENOSIS OF A BARE METAL STENT. PRIOR TO THE ADVANCEMENT OF THE VSX DEVICE, THE PHYSICIAN PERFORMED A THROMBECTOMY WITH A PENUMBRA SYSTEM TO REMOVE THROMBUS FROM THE BARE METAL STENT. THE PHYSICIAN ADVANCED THE VSX DEVICE THROUGH A 6FR COOK INTRODUCER SHEATH OVER AN 0.018" V18 WIRE AND ATTEMPTED TO DEPLOY THE DEVICE. HOWEVER, AFTER APPROXIMATELY 10CM OF THE VSX DEVICE WAS EXPANDED, THE DEPLOYMENT LINE BROKE. WITH THE VSX DEVICE NOT FULLY DEPLOYED, THE PHYSICIAN CUT THE DELIVERY CATHETER AND LOCATED THE REMAINDER OF THE DEPLOYMENT LINE AND TRIED TO CONTINUE DEPLOYING THE DEVICE WITH HEMOSTATS. WITH THE INABILITY TO CONTINUE DEPLOYMENT, THE PHYSICIAN DECIDED TO PERFORM A CUT DOWN TO THE VESSEL AND CUT THE DEPLOYMENT CATHETER AS CLOSE THE STENT AS HE COULD AND LEAVE THE UNDEPLOYED VSX DEVICE, DEPLOYMENT CATHETER AND DEPLOYMENT LINE IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18531586 ↗
• MalfunctionJun 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE LEFT SUPERFICIAL FEMORAL ARTERY FOR TREATMENT OF STENOSIS. AFTER THE DEVICE WAS SUCCESSFULLY IMPLANTED, THE PHYSICIAN REMOVED THE DELIVERY CATHETER. UPON REMOVAL OF THE DELIVERY CATHETER IT WAS DISCOVERED THAT THE DISTAL TIP HAD SEPARATED FROM THE CATHETER INSIDE THE PATIENT. AN ANGIOGRAM WAS PERFORMED AND THE DISTAL TIP WAS LOCATED IN THE IMPLANTED DEVICE. THE DECISION WAS MADE TO ADVANCE AN ADDITIONAL 5MM X 5CM VSX DEVICE AND PIN THE DISTAL TIP TO THE WALL OF THE PREVIOUSLY IMPLANTED VSX DEVICE. A FINAL ANGIOGRAM WAS PERFORMED TO VERIFY THAT THE DISTAL TIP WAS PINNED AGAINST THE WALL AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis

  MAUDE report 14606369 ↗
• InjuryJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A GORE® VIABAHN® ENDOPROSTHESIS WAS TO BE IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY TO TREAT OCCLUSION. AFTER THE DEVICE WAS ADVANCED UP AND OVER THE AORTIC BIFURCATION TO THE TREATMENT SIGHT, THE PHYSICIAN STARTED TO DEPLOY THE DEVICE WHEN THE DEPLOYMENT LINE BROKE. UNDER FLUOROSCOPY IT WAS NOTICED THAT APPROXIMATELY HALF OF THE DEVICE WAS DEPLOYED. THE PHYSICIAN ADVANCED THE INTRODUCER SHEATH TO THE DEVICE AND TRIED REMOVE THE DEVICE AND SHEATH IN TANDEM. DURING THE ATTEMPTED REMOVAL, THE DEVICE HAD BECOME DISLODGED IN THE COMMON FEMORAL ARTERY. ON AN UNKNOWN DATE, THE PATIENT HAD A SURGICAL CONVERSION PERFORMED TO EXPLANT THE DEVICE.

  Patient problems: No Code Available

  MAUDE report 11158291 ↗
• InjuryNov 29, 2018Device Damaged by Another Device; Activation Failure; Device Damaged by Another Device; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT PRESENTED WITH THROMBOSIS IN SUPERFICIAL FEMORAL ARTERY (SFA). A ZILVER PTX STENT WAS DEPLOYED FIRST BUT BLOOD FLOW WAS NOT RE-ESTABLISHED. CONSEQUENTLY, A GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED IN ORDER TO COVER THE STENOTIC LESION. AS REPORTED, THE ZILVER PTX STENT AND THE VIABAHN DEVICE WERE AT LEAST 2 CM APART IN THE NATIVE VESSEL WITH NO OVERLAP. DURING DEPLOYMENT OF THE VIABAHN DEVICE, THE DEVICE EXPANDED ABOUT 2 CM WHEN THE DEPLOYMENT LINE BECAME STUCK. FURTHER DEPLOYMENT WAS NOT POSSIBLE. A LONGER SHEATH WAS INSERTED AND ATTEMPTS WERE MADE TO CAPTURE THE PARTIALLY EXPANDED VIABAHN DEVICE. IN THE PROCESS, THE VIABAHN DEPLOYMENT LINE BECAME ENTANGLED WITH THE ZILVER PTX STENT. AS A RESULT, A CUT DOWN WAS PERFORMED IN THE PATIENT'S RIGHT SFA. THE VIABAHN DEVICE WAS CUT INTO TWO SECTIONS AND REMOVED ALONG WITH THE ZILVER PTX STENT. THE ARTERY WAS REPAIRED AND PATIENT WAS SENT TO RECOVERY.

  Patient problems: Perforation

  MAUDE report 8117731 ↗