GORE VIABAHN Endoprosthesis VBCR131002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132645923), received between Mar 11, 2024 and Jul 24, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR STENOSIS IN THE CEPHALIC ARCH/SUBCLAVIAN VEIN WHERE A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS INTENDED TO BE USED. ACCESS TO THE TARGET SITE WAS SUCCESSFULLY ACHIEVED VIA A 10FR BOSTON SCIENTIFIC SUPER SHEATH AND A 180 CM BOSTON SCIENTIFIC BENTSON GUIDEWIRE WITHOUT ANY RESISTANCE. UPON DELIVERY OF THE VIABAHN DEVICE, DEPLOYMENT WAS INITIATED BY PULLING ON THE DEPLOYMENT LINE. DURING THIS PROCESS, THE PHYSICIAN ENCOUNTERED RESISTANCE. THE ENDOPROSTHESIS PARTIALLY EXPANDED AT THE DISTAL END; HOWEVER, EXPANSION CEASED MIDWAY AND COULD NOT BE COMPLETED. MULTIPLE ATTEMPTS WERE MADE TO FULLY DEPLOY THE DEVICE, BUT RESISTANCE ALONG THE DEPLOYMENT LINE PERSISTED. ULTIMATELY, THE DEVICE WAS RETRIEVED IN TANDEM WITH THE SHEATH AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING BALLOON ANGIOPLASTY. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT. NO TORTUOUS ANATOMY NOR CALCIFICATION WAS PRESENT IN THE TARGET TREATMENT AREA. HOWEVER, A PREVIOUSLY PLACED STENT (MANUFACTURER UNKNOWN) WAS PRESENT AT THE TREATMENT SITE. THE PHYSICIAN IS UNSURE WHAT CAUSED THE DEPLOYMENT LINE TO BECOME STUCK SINCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592942 ↗
• MalfunctionJun 10, 2024Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT A REVISION FOR AN ARTERIOVENOUS (AV) FISTULA IN THE UPPER ARM USING A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE). IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO REACH THE TARGET TREATMENT AREA WITHOUT ANY RESISTANCE. THE PHYSICIAN WAS READY TO INITIATED DEPLOYMENT WHEN THEY NOTICE SOME RESISTANCE WHILE PULLING THE DEPLOYMENT LINE. THE VIABAHN DEVICE STARTED TO BOWSTRING. THE PHYSICIAN DID NOT TRY TO FORCE IT OPEN SO THEY TOOK OUT THE VIABAHN DEVICE OUT THROUGH THE SHEATH. THERE WAS NO DEVICE EXPANSION. 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 19506044 ↗
• MalfunctionMar 11, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR CENTRAL VEIN STENOSIS USING A 13 MM X 10 CM GORE® VIABAHN® ENDOPROSTHESIS DEVICES (VIABAHN® DEVICES) IN THE INNOMINATE VEIN / VENA CAVA. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT THROUGH A DIALYSIS ACCESS GRAFT IN THE UPPER ARM USING A 10F TERUMO INTRODUCER SHEATH OVER AN 0.035" GUIDEWIRE (UNKNOWN BRAND) TO THE TARGET TREATMENT SITE. REPORTEDLY, THE PHYSICIAN PULLED THE DEPLOYMENT LINE AND IT UNZIPPED HUB TO TIP, BUT GOT STUCK AT THE TURN AROUND AND COULD NOT BE PULLED. THE ENDOPROSTHESIS STARTED TO BOW WHEN FORCE WAS APPLIED TO PULL THE LINE. THE DECISION WAS MADE TO WITHDRAW THE DELIVERY CATHETER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BD DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882202 ↗
• MalfunctionMar 11, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR CENTRAL VEIN STENOSIS USING A 13 MM X 10 CM GORE® VIABAHN® ENDOPROSTHESIS DEVICES (VIABAHN® DEVICES) IN THE INNOMINATE VEIN / VENA CAVA. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT THROUGH A DIALYSIS ACCESS GRAFT IN THE UPPER ARM USING A 10F TERUMO INTRODUCER SHEATH OVER AN 0.035" GUIDEWIRE (UNKNOWN BRAND) TO THE TARGET TREATMENT SITE. REPORTEDLY, DURING DEPLOYMENT, THE PHYSICIAN PULLED THE DEPLOYMENT LINE AND THE ENDOPROSTHESIS INITIATED EXPANSION. IT EXPANDED APPROXIMATELY 1 CENTIMETER, BEFORE THE LINE COULD NOT BE PULLED ANY MORE. THE DELIVERY CATHETER AND THE SHEATH WERE WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BD DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882130 ↗