GORE VIABAHN Endoprosthesis with Heparin VBH130502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132623280), received between Jul 1, 2019 and Feb 11, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2021Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT IN THE SUPERIOR VENA CAVA, ACCESS WAS MADE FROM THE GROIN AREA. AFTER SHEATH PLACEMENT, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICE) WAS DELIVERED TO THE TREATMENT AREA. DEPLOYMENT WAS INITIATED AND THE VSX DEVICE EXPANDED ABOUT HALFWAY WHEN DEPLOYMENT STOPPED. AS REPORTED, THE PHYSICIAN MADE ATTEMPTS TO COMPLETE THE DEPLOYMENT BY PULLING STEADILY ON THE LINE. HOWEVER, THE DEPLOYMENT LINE BROKE. ACCESS WAS THEN MADE FROM THE AXILLARY ARTERY AND A BALLOON CATHETER WAS DELIVERED TO THE TREATMENT SITE. THE BALLOON WAS INFLATED AND THE VSX DEVICE EXPANDED COMPLETELY. THE PROCEDURE ENDED WITH GOOD RESULTS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11314726 ↗
• MalfunctionJan 2, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR UPPER ARM FISTULA REPAIR. THE GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED INTO POSITION AND THE DEPLOYMENT LINE PULLED. WHILE PULLING THE DEPLOYMENT LINE, THE DEPLOYMENT LINE BROKE. THE DOCTOR WAS ABLE TO GRASP THE PARTIALLY DEPLOYED DEVICE WITH A PAIR OF HEMOSTATS AND PULLED IT OUT. WHEN OUT OF THE PATIENT THE DOCTOR OBSERVED THE TIP OF THE CATHETER WAS STILL IN THE PATIENT ON THE WIRE. THE TIP WAS REMOVED WITH THE WIRE.

  Patient problems: Fistula

  MAUDE report 9541186 ↗
• MalfunctionJul 1, 2019Failure to Unfold or Unwrap; Activation Failure; Failure to Unfold or Unwrap; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE BY THE DOCTOR: THE PATIENT PRESENTED FOR OPEN ARCH REPAIR. THE DOCTOR PLACED THE GORE® VIABAHN® ENDOPROSTHESIS IN THE INNOMINATE ARTERY. WHEN THE DEPLOYMENT LINE WAS PULLED, THE DOCTOR OBSERVED IT TO APPEAR TO UNRAVEL. THE GORE® VIABAHN® ENDOPROSTHESIS DID NOT COMPLETELY OPEN. THE DOCTOR CONTINUED THE REPAIR USING OPEN TECHNIQUE.

  Patient problems: No Information

  MAUDE report 8750353 ↗