GORE VIABAHN Endoprosthesis VBCR080501ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132623501), received between Aug 6, 2020 and Oct 15, 2025 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR AN ARTERIOVENOUS (AV) FISTULA IN THE UPPER ARM USING A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE). IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE VIABAHN DEVICE OVER A 0.035" GLIDEWIRE THROUGH A CORDIS 8FR INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED RESISTANCE DURING ADVANCEMENT. WHILE ATTEMPTING TO DEPLOY THE DEVICE, THE PHYSICIAN WAS ABLE TO PULL THE DEPLOYMENT LINE (SOME STRING WAS PULLED), BUT FULL DEPLOYMENT WAS UNSUCCESSFUL. THE DEVICE WAS SUBSEQUENTLY WITHDRAWN THROUGH THE SHEATH, AND NO COMPONENTS REMAINED INSIDE THE PATIENT. IT WAS REPORTED THAT THE TARGET TREATMENT AREA HAD BEEN REACHED PRIOR TO THE DEPLOYMENT ATTEMPT, AND SOME DEVICE EXPANSION WAS OBSERVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE PHYSICIAN WAS UNCERTAIN ABOUT THE CAUSE OF THE DEPLOYMENT ISSUE, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306012 ↗
• MalfunctionSep 2, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: A PATIENT PRESENTED FOR TREATMENT OF A DIALYSIS ACCESS OUTFLOW STENOSIS. AS REPORTED, THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE) WAS PLACED AT THE TREATMENT ZONE AND DEPLOYMENT WAS STARTED. HOWEVER, THE DEPLOYMENT LINE BECAME STUCK AFTER IT UNRAVELED ABOUT A FOURTH OF THE WAY ON THE FIRST LAYER. AS THE SECOND LAYER WAS NOT UNRAVELED, THE VIABAHN® DEVICE REMAINED CONSTRAINED AND WAS REMOVED WITH NO ISSUES AND NO IMPACT TO THE PATIENT. A NEW VIABAHN® DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22940300 ↗
• InjuryAug 8, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE UPPER ARM DURING TREATMENT OF STENOSIS IN A PREEXISTING ARTERIOVENOUS ACCESS GRAFT. ON AN UNKNOWN DATE THE PATIENT HAD AN ARTERIOVENOUS ACCESS GRAFT (MANUFACTURER UNKNOWN) IMPLANTED IN THE UPPER ARM. ON (B)(6) 2023, THE PHYSICIAN PERFORMED A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH A 4MM BALLOON (MANUFACTURER UNKNOWN) FOLLOWED BY AN 8MM BALLOON (MANUFACTURER UNKNOWN). A VSX DEVICE WAS SUCCESSFULLY IMPLANTED TO RELINE THE GRAFT. HOWEVER, DURING THE REMOVAL OF THE DELIVERY CATHETER, THE DISTAL TIP HAD BECOME STUCK ON THE OUTER EDGE OF THE VSX DEVICE. THE PHYSICIAN DECIDED TO CREATE ANOTHER ACCESS SITE ON THE OPPOSITE SIDE AND ADVANCE AN 0.018" GUIDEWIRE (MANUFACTURER UNKNOWN) THROUGH THE VSX DEVICE AND ADVANCE A 4MM BALLOON (MANUFACTURER UNKNOWN) TO POST DILATE. THE DELIVERY CATHETER WAS THAN SUCCESSFULLY REMOVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. 2203-A: OTHER (PATIENT SYMPTOM CODE) USED TO CAPTURE SECONDARY ACCESS SITE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17484936 ↗
• MalfunctionFeb 24, 2022Premature Activation; Premature Activation

  THE FOLLOWING WAS REPORTED TO GORE BY USER FACILITY REPRESENTATIVE: DURING VASCULAR ACCESS TREATMENT, A GORE® VIABAHN® ENDOPROSTHESIS DID NOT INITIALLY DEPLOY, THEN STARTED DEPLOYING (EXPANDING) WHEN TRYING TO REMOVE AND IT WAS CAPTURED WITH A SHEATH. NO PATIENT HARM WAS REPORTED. FURTHER INFORMATION WAS REQUESTED BUT NOT MADE AVAILABLE AS OF TODAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595278 ↗
• MalfunctionAug 6, 2020Activation Failure; Activation Failure

  ON (B)(6) 2020, A GORE® VIABAHN® ENDOPROSTHESIS (VSX) WAS TO BE PLACED FOR TREATMENT OF A FAILED FISTULA IN THE BRACHIAL ARTERY. HOWEVER, WHEN THE PHYSICIAN WAS DEPLOYING THE DEVICE IT PARTIALLY EXPANDED THEN STOPPED. THE PHYSICIAN WAS NOT ABLE TO FULLY DEPLOY THE DEVICE AND REMOVED THE DEVICE AND SHEATH IN TANDEM. AN ADDITIONAL VSX WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10375878 ↗