GORE VIABAHN Endoprosthesis VBCR111002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132645886), received between Apr 30, 2024 and Oct 20, 2025 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2025Difficult or Delayed Activation; Separation Problem; Difficult or Delayed Activation; Separation Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN ETIOLOGY WHERE A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS INTENDED TO BE PLACED IN THE SUBCLAVIAN ARTERY. THE PHYSICIAN USED A 10FR TERUMO INTRODUCER SHEATH AND A 0.035" COOK MEDICAL ROADRUNNER® PC HYDROPHILIC WIRE GUIDE TO ADVANCE THE VIABAHN DEVICE TO THE TARGET TREATMENT AREA WITH NO RESISTANCE. DEPLOYMENT OF THE DEVICE WAS INITIATED; HOWEVER, THE VIABAHN DEVICE FAILED TO DEPLOY. IT IS UNCLEAR HOW MUCH OF THE DEPLOYMENT LINE WAS PULLED PRIOR TO THE ATTEMPT TO WITHDRAW THE CONSTRAINED DEVICE. DURING THE WITHDRAWAL OF THE VIABAHN DEVICE IN TANDEM WITH THE SHEATH, RESISTANCE WAS ENCOUNTERED. SUBSEQUENTLY, THE DEVICE UNINTENTIONALLY DISLODGED WITHIN THE PATIENT¿S UPPER ARM. A SURGICAL CUTDOWN WAS REQUIRED TO RETRIEVE THE DEPLOYED VIABAHN DEVICE. NO PRIOR ATTEMPTS WERE MADE TO RETRIEVE THE DISLODGED ENDOPROSTHESIS THROUGH NON-SURGICAL MEANS. THE PROCEDURE WAS COMPLETED BY SUTURING THE PATIENT¿S ARTERY. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED. THE PHYSICIAN NOTED THAT THERE WERE NO INDICATIONS OF TORTUOUS ANATOMY OR CALCIFICATION, AND THE ROOT CAUSE OF THE DEPLOYMENT ISSUE REMAINS UNDETERMINED.

  Patient problems: Failure of Implant

  MAUDE report 23337702 ↗
• MalfunctionNov 26, 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 CEPHALIC ARCH DURING TREATMENT OF STENOSIS. IT WAS REPORTED THAT THE STENOSIS WAS PRE-DILATED WITH A 4 MM CONQUEST BALLOON. THE PHYSICIAN THEN ADVANCED THE VSX DEVICE THROUGH A 10FR TERUMO INTRODUCER SHEATH, OVER A 0.035" STIFF ROAD RUNNER GUIDEWIRE AND ACROSS THE LESION. REPORTEDLY, AFTER DEPLOYMENT WAS INITIATED THE DEPLOYMENT LINE GOT STUCK. THE PHYSICIAN ATTEMPTED TO PULL THE DEPLOYMENT LINE A FEW MORE TIMES WITH NO SUCCESS AND WITH NO DEVICE EXPANSION THE VSX DEVICE WAS REMOVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778904 ↗
• MalfunctionAug 8, 2024Premature Activation; Premature Activation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, AN 11MM X 10CM GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE UPPER ARM DURING TREATMENT OF STENOSIS IN A DIALYSIS ACCESS GRAFT (MANUFACTURER UNKNOWN). AFTER AN ANGIOPLASTY WAS PERFORMED, THE PHYSICIAN ATTEMPTED TO ADVANCE THE VSX DEVICE. HOWEVER, THE PHYSICIAN MET RESISTANCE WHILE ADVANCING THE VSX DEVICE THROUGH THE STENOSIS AND THE CATHETER STARTED KINKING. WITH THE INABILITY TO ADVANCE THE VSX DEVICE THROUGH THE STENOSIS, THE PHYSICIAN ATTEMPTED TO REMOVE THE VSX DEVICE. HOWEVER, THE VSX DEVICE HAD DISTAL EXPANSION, AND THE PHYSICIAN WAS UNABLE TO REMOVE THE VSX DEVICE THROUGH THE 10FR CORDIS BRITE TIP INTRODUCER SHEATH. THE PHYSICIAN REMOVED THE 0.035" TERUMO GLIDEWIRE ADVANTAGE, INTRODUCER SHEATH AND VSX DEVICE IN TANDEM. A 13MM X 10CM VSX DEVICE WAS SUCCESSFULLY DELIVERED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19941929 ↗
• MalfunctionApr 30, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A PROCEDURE FOR A AV FISTULA IN THE UPPER ARM USING A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE). IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO DEPLOY THE VIABAHN DEVICE INSIDE THE BODY AS THE DEPLOYMENT LINE WOULD NOT DETACH FROM THE STENT.

  Patient problems: Insufficient Information

  MAUDE report 19218273 ↗