GORE VIABAHN Endoprosthesis VBCR050502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132623334), received between Mar 25, 2025 and Nov 3, 2025 — 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.

• MalfunctionNov 3, 2025Activation Failure; Activation Failure

  ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT AN UNKNOWN ETIOLOGY WHERE A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS INTENDED TO BE IMPLANTED IN AN UNKNOWN ANATOMICAL LOCATION. THE PHYSICIAN REACHED THE TARGET TREATMENT AREA AND INITIATED DEPLOYMENT BY PULLING THE DEPLOYMENT LINE. THE DEPLOYMENT LINE WAS ABLE TO UNZIP FROM THE VIABAHN DEVICE, HOWEVER, THE VIABAHN ENDOPROSTHESIS WAS UNABLE TO EXPAND AND REMAINED ON THE DELIVERY CATHETER. THE VIABAHN DEVICE WAS REMOVED FROM THE PATIENT WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED USING A NEW VIABAHN DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452127 ↗
• MalfunctionAug 26, 2025Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDER WENT ENDOVASCULAR TREATMENT OF A VENOUS ANASTOMOSIS OF AN AV GRAFT WITH A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE). HOWEVER, THE DEPLOYMENT LINE GOT STUCK WHEN THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THIS VSX DEVICE IN THE VENOUS ANASTOMOSIS OF AN AV GRAFT. HE TRIED ONE MORE TIME BUT FELT IT WAS SAFER TO REMOVE THIS DEVICE. THE PHYSICIAN SUCCESSFULLY DEPLOYED A NEW VSX DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22899663 ↗
• MalfunctionMar 25, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE WHERE A FISTULA GRAM IN THE RIGHT (UNKNOWN IF IT WAS UPPER, LOWER, OR FOREARM) ARM WAS PERFORMED WHERE A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE) WAS USED IN A FISTULA (UNKNOWN IF ARTIFICIAL GRAFT OR NATIVE FISTULA). IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT USING AN UNKNOWN SIZE / BRAND INTRODUCER SHEATH OVER AN UNKNOWN SIZE / BRAND GUIDEWIRE TO THE TARGET TREATMENT ZONE. IT IS UNKNOWN IF THERE WERE ADVANCEMENT ISSUES. REPORTEDLY, THE DEPLOYMENT LINE WAS PULLED AND BROKE. IT WAS REPORTED THAT THE ENDOPROSTHESIS DID NOT DEPLOY. IT IS UNKNOWN IF THERE WAS DISTAL EXPANSION. THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER GORE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689202 ↗