GORE VIABAHN Endoprosthesis with Heparin VBHR071001ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132622962), received between Jun 13, 2025 and Sep 2, 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.

• MalfunctionSep 2, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, DURING TREATMENT OF A STENOSED A-V FISTULA IN THE PATIENT'S LEFT ARM, AN 8FR SHEATH (UNSPECIFIED BRAND) WAS USED TO ADVANCE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) OVER AN 0.35 WIRE (UNSPECIFIED BRAND). THE VIABAHN® DEVICE WAS PLACED AT THE INTENDED TREATMENT SITE AND DEPLOYMENT WAS STARTED. HOWEVER, THE CATHETER KEPT BOWSTRINGING AND DEPLOYMENT COULD NOT BE CONTINUED. THE VIABAHN® DEVICE WAS WITHDRAWN FROM THE PATIENT WITH NO ISSUES. A NEW VIABAHN® DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. AS REPORTED, THE PHYSICIAN TRIED TO DEPLOY THE REMOVED VIABAHN® DEVICE ON THE BACK TABLE. THE PHYSICIAN REPORTED THAT IT SEEMED THE DEPLOYMENT LINE DID NOT APPEAR TO BE 'FULLY CONNECTED', THUS, NOT ALLOWING FOR DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939374 ↗
• MalfunctionJun 13, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR AN ARTERIOVENOUS (AV) FISTULA REPAIR USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) IN THE BRACHIAL VEIN (UPPER ARM). IT WAS REPORTED DURING A PROCEDURE; A PHYSICIAN ADVANCED A 7MM X 10CM VIABAHN DEVICE OVER A TERUMO STIFF GLIDEWIRE (.035" GUIDEWIRE) THROUGH A TERUMO 8FR INTRODUCER SHEATH. AFTER PULLING THE DEPLOYMENT LINE A FEW CENTIMETERS, THE PHYSICIAN NOTICED INCREASING RESISTANCE AND OPTED TO STOP TO AVOID POTENTIAL BREAKAGE OF THE DEPLOYMENT LINE. HOWEVER, THE DEPLOYMENT LINE BECAME STUCK, PREVENTING FURTHER DEPLOYMENT. IT WAS REPORTED THAT THE DEPLOYMENT LINE WAS NOT PULLED TOO QUICKLY, AND THERE WERE NO ISSUES DURING ADVANCEMENT OR WITHDRAWAL. NO DISTAL EXPANSION OR STENT OPENING OCCURRED. THE UNDEPLOYED VIABAHN DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW 7MM X 10CM VIABAHN DEVICE. THE PHYSICIAN IS UNSURE OF THE CAUSE OF THE ISSUE, AS IT IS SOMETHING HE HAS NEVER ENCOUNTERED BEFORE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206558 ↗