GORE VIABAHN Endoprosthesis with Heparin VBHR070702ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132624058), received between Nov 15, 2024 and Jun 4, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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.

• MalfunctionJun 4, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT A DIALYSIS GRAFT STENT PROCEDURE WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED TO BE USED. THE PHYSICIAN WAS ABLE TO REACH THE TARGET TREATMENT AREA BY USINGS AN UNKNOWN INTRODUCER SHEATH AND AN UNKNOWN GUIDEWIRE. DEPLOYMENT WAS INITIATED. WHEN PULLING THE DEPLOYMENT LINE, THE PHYSICIAN EXPERIENCED RESISTANCE. THE DEPLOYMENT LINE WAS DIFFICULT TO PULL SO THEY WITHDREW THE VIABAHN DEVICE AND DISCARDED IT. 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 22142810 ↗
• MalfunctionNov 15, 2024

  PLACED INTO PATIENT UPON ATTEMPTED DEPLOYMENT OF STENT. PHYSICIAN HAD DIFFICULTLY AND ELECTED TO REMOVE. UPON INSPECTION, IT WAS NOTED THE STENT WAS NOT IN ITS PROPER POSITION BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694041 ↗