GORE VIABAHN Endoprosthesis VBCR100502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132645800), received between Sep 30, 2024 and Jan 16, 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.

• MalfunctionJan 16, 2026Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A LEFT UPPER ARM AV FISTULA ACCESS IN THE CEPHALIC ARCH. IT IS NOT SPECIFIED IF THERE WAS A PRE-EXISTING DEVICE. AS REPORTED, THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE) REACHED THE INTENDED TREATMENT SITE AND DEPLOYMENT WAS STARTED. HOWEVER, THE VIABAHN® DEVICE DID NOT EXPAND COMPLETELY AT THE TREATMENT AREA (CEPHALIC ARCH). THE VIABAHN® DEVICE COULD NOT BE RELEASED FROM THE CATHETER UNTIL IT WAS PULLED BACK MORE PERIPHERALLY INTO THE CEPHALIC VEIN. IT WAS REPORTED THE CEPHALIC VEIN AREA WAS CONSIDERED TOO SMALL FOR THE VIABAHN® DEVICE. THE PHYSICIAN CHOSE A LARGER STENT (12X80 PROTEGE) TO TRAP THE VIABAHN® DEVICE TO PATIENT'S VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 24096741 ↗
• MalfunctionJul 15, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS ACCESS MAINTENANCE PROCEDURE TO ADDRESS A VENOUS OUTFLOW STENOSIS. THE INTERVENTION WAS PERFORMED IN AN UPPER EXTREMITY ARTERIOVENOUS (AV) ACCESS CIRCUIT; HOWEVER, IT IS UNKNOWN WHETHER THE ACCESS WAS VIA A GRAFT OR A NATIVE FISTULA. THE PROCEDURE INVOLVED THE INTENDED USE OF A GORE® VIABAHN® ENDOPROSTHESIS (GORE® VIABAHN® DEVICE). IT WAS REPORTED THE PHYSICIAN ACHIEVED VASCULAR ACCESS USING AN 8F INTRODUCER SHEATH (MANUFACTURER UNSPECIFIED), IN CONJUNCTION WITH A BOSTON SCIENTIFIC 0.035" ZIPWIRE¿ HYDROPHILIC GUIDEWIRE. IT IS NOT KNOWN WHETHER PRE-DILATION OF THE TARGET LESION WAS PERFORMED PRIOR TO ATTEMPTED DEVICE DEPLOYMENT. THE GORE® VIABAHN® DEVICE DELIVERY SYSTEM WAS REPORTEDLY ADVANCED TO THE INTENDED TREATMENT SITE. DURING THE DEPLOYMENT PHASE, THE OPERATOR ATTEMPTED TO ACTUATE THE DEPLOYMENT MECHANISM BY PULLING THE DEPLOYMENT LINE. HOWEVER, THE LINE BECAME IMMOBILE AND COULD NOT BE RETRACTED FURTHER. IT WAS REPORTED THAT THE DEPLOYMENT ATTEMPT OCCURRED AT AN ATYPICAL ANGLE, WHICH MAY HAVE CONTRIBUTED TO THE MALFUNCTION. THERE WAS NO REPORTED BREAKAGE OF THE DEPLOYMENT LINE, NOR WAS THERE ANY REPORT OF INITIATION OF DISTAL END

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22510211 ↗
• MalfunctionSep 30, 2024Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN AN UNKNOWN ANATOMICAL LOCATION DURING TREATMENT OF AN UNKNOWN ETIOLOGY. DURING THE DEPLOYMENT OF THE VSX DEVICE, THE DEPLOYMENT LINE STUCK AND STARTED TO BOW STRING. THE VSX DEVICE WAS REMOVED THROUGH THE INTRODUCER SHEATH (SIZE AND MANUFACTURER UNKNOWN) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL VSX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334092 ↗