GORE VIABAHN Endoprosthesis with Heparin VBHR070501ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132622924), received between Nov 13, 2024 and Jul 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Break; Activation Failure; Break; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR A STENOSED FISTULA WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS ATTEMPTED TO BE USED IN THE FEMORAL ARTERY. IT WAS REPORTED DURING THE PROCEDURE, WHILE ADVANCING THE VIABAHN DEVICE OVER A TERUMO GLIDEWIRE ADVANTAGE .035" GUIDEWIRE THROUGH AN 8FR CORDIS INTRODUCER SHEATH, THE PHYSICIAN-INITIATED DEPLOYMENT BY PULLING THE DEPLOYMENT LINE. AFTER PULLING APPROXIMATELY 18 INCHES, THE DEPLOYMENT LINE BROKE. IT IS UNKNOWN WHETHER EXCESSIVE SPEED OR FORCE WAS USED WHEN PULLING THE DEPLOYMENT LINE. REPORTEDLY, THE TARGET TREATMENT AREA WAS REACHED PRIOR TO INITIATING DEPLOYMENT. THERE WAS NO CALCIFICATION NOTED AND THERE WAS NO RESISTANCE DURING ADVANCEMENT. IT WAS REPORTED THERE WAS NO DISTAL EXPANSION OR OPENING OF THE STENT INITIATED. THE PHYSICIAN REMOVED THE DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE USING A NEW 7MM X 10CM VIABAHN DEVICE. THE PHYSICIAN REMAINS UNSURE ABOUT THE CAUSE OF THE ISSUE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395229 ↗
• MalfunctionNov 13, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR AN AVD CLOT WHERE A 7 MM X 5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (GORE® VIABAHN® DEVICE) WAS USED IN AN UPPER ARM SYNTHETIC LOOP GRAFT (BRAND UNKNOWN, AND DATE OF PLACEMENT UNKNOWN). IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT USING AN 8F TERUMO INTRODUCER SHEATH OVER AN UNKNOWN BRAND 0.035" GUIDEWIRE TO THE TARGET TREATMENT ZONE. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. AT THE TARGET TREATMENT SITE, THE DEPLOYMENT LINE WAS PULLED AND BECAME STUCK. REPORTEDLY, THE DEPLOYMENT LINE DID NOT BREAK. THE DECISION WAS MADE TO WITHDRAW THE DELIVERY CATHETER. AN ATTEMPT TO PULL THE DELIVERY CATHETER BACK INTO THE SHEATH WAS UNSUCCESSFUL. THE INTRODUCER SHEATH AND DELIVERY CATHETER WERE WITHDRAWN TOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER SHEATH AND GORE® VIABAHN® DEVICE (SAME SIZE). IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675673 ↗