GORE VIABAHN Endoprosthesis with Heparin VBHR111002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132646104), received between Apr 15, 2024 and Jun 8, 2024 — classified as 1 injury, 1 malfunction.

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 8, 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 THE ARM DURING TREATMENT OF AN ARTERIOVENOUS ACCESS REVISION. AFTER THE DEVICE WAS ADVANCED THROUGH THE TERUMO INTRODUCER SHEATH (SIZE UNKNOWN) OVER AN 0.035" BENTSON GUIDE WIRE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE VSX DEVICE IN THE PREVIOUSLY IMPLANTED ARTERIOVENOUS ACCESS GRAFT (MANUFACTURER UNKNOWN). HOWEVER, AFTER DEPLOYMENT WAS INITIATED THE DEPLOYMENT LINE GOT HUNG UP AT THE TURN AROUND AND WOULD NOT DEPLOY. WITH NO DEVICE EXPANSION THE VSX DEVICE WAS REMOVED THOUGH THE INTRODUCER SHEATH. A NEW VSX DEVICE WAS SUCCESSFULLY DELIVERED TO COMPLETE THE CASE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19493564 ↗
• InjuryApr 15, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, TWO GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICES) WERE IMPLANTED TO REPAIR A POPLITEAL ANEURYSMS. IT WAS REPORTED ON AN UNKNOWN DATE AFTER THE IMPLANT PROCEDURE THROMBOSIS OF THE REPAIRED SITE WAS NOTED. REPORTEDLY, THE PHYSICIAN BELIEVES, DUE TO TIME OF ONSET AND AGGRESSIVENESS OF THROMBOSIS THAT THE PATIENT HAD HEPARIN INDUCED THROMBOCYTOPENIA (HIT). ADDITIONALLY, ON AN UNKNOWN DATE A REINTERVENTION OCCURRED (BYPASS REPAIR) IN WHICH BOTH VIABAHN DEVICES WERE EXPLANTED. AT AN UNKNOWN TIME SHORTLY AFTER THE BYPASS REPAIR THE SITE WAS THROMBOSED AS WELL. REPORTEDLY, ON AN UNKNOWN DATE AFTER PROCEDURE A PLATELET FACTOR 4 (PF4) TEST WAS COMPLETED WITH THE RESULT OF POSITIVE ANTIBODIES IN THE PATIENT. IT IS UNKNOWN WHAT TREATMENT THE PATIENT RECEIVED AFTER THE POSITIVE PF4, HOWEVER, THE PATIENT IS DOING WELL AND THE SYMPTOMS OF HIT HAVE RESOLVED.

  Patient problems: Thrombocytopenia; Thrombosis/Thrombus

  MAUDE report 19110963 ↗