GORE VIABAHN Endoprosthesis VBCR081002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132623532), received between Sep 11, 2024 and Apr 8, 2026 — classified as 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Difficult or Delayed Positioning; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT PRESENTED FOR TREATMENT IN THE LEFT AXILLARY VEIN DUE TO CHRONIC REOCCURRING STENOSIS. DURING THE PROCEDURE, THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE) WAS ADVANCED OVER AN 0.035 ANGIODYNAMICS BENTSON GUIDEWIRE. AS REPORTED, THE VIABAHN® DEVICE WAS ADVANCED WITHOUT THE AID OF A SHEATH. DEPLOYMENT WAS STARTED WHEN THE VIABAHN® STENT STARTED MOVING DISTALLY FROM THE TREATMENT AREA. THE VIABAHN® STENT WAS REPOSITIONED, BUT THE VIABAHN® LINE WAS STUCK AND DEPLOYMENT COULD NOT BE CONTINUED. THE CONSTRAINED VIABAHN® DEVICE WAS REMOVED FROM THE PATIENT WITH NO ISSUES AND NO HARM TO PATIENT. AS REPORTED, THE PHYSICIAN SAID THE ISSUE LIKELY OCCURRED BECAUSE HE REPOSITIONED WHILE DEPLOYING THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824008 ↗
• MalfunctionSep 19, 2024Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED BY THE FSA: ON (B)(6) 2024, A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS INTENDED FOR USE IN AN TO LINE A FISTULA FOR DIALYSIS AV ACCESS. THE PHYSICIAN REPORTED THERE WAS FAILURE TO DEPLOY THE DEVICE BECAUSE THE DEPLOYMENT LINE WAS STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER VIABAHN DEVICE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260323 ↗
• MalfunctionSep 11, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR AN UNKNOWN REASON WHERE AN 8 MM X 10 CM GORE® VIABAHN® ENDOPROSTHESIS WAS INTENDED TO BE USED IN AN UNKNOWN LOCATION. IT WAS REPORTED THE PHYSICIAN ADVANCED THE DELIVERY CATHETER USING AN 8F INTRODUCER SHEATH (BRAND UNKNOWN) OVER AN .035" ADVANTAGE GLIDEWIRE TO THE TARGET TREATMENT ZONE. REPORTEDLY, DURING DEPLOYMENT THE LINE WAS PULLED AND BECAME CAUGHT, CAUSING THE DEPLOYMENT LINE TO BECOME STRETCHED OUT NEAR THE TURN AROUND. REPORTEDLY, DEPLOYMENT WAS ABORTED, AND THE PHYSICIAN WITHDREW THE CATHETER, WITH THE ENDOPROSTHESIS FULLY CONSTRAINED. THERE WAS NO DISTAL EXPANSION INITIATED OF THE ENDOPROSTHESIS AND THE DEPLOYMENT LINE DID NOT BREAK. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191361 ↗