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GORE VIABAHN VBX Balloon Expandable Endo BXA093901ARecalls & reported problems

W. L. Gore & Associates, Inc. · VIABAHN BX BALLOON EXP ENDO 9mmX39mm 8Fr 80cmCath Heparin · Class 3 · Implant

All models of GORE VIABAHN VBX Balloon Expandable Endo (111)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132637348), received between Dec 30, 2020 and Mar 2, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P160021); they may or may not involve this specific model.

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

Device problems

  • Detachment of Device or Device Component2

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    ON (B)(6) 2023, THE PATIENT UNDERWENT TREATMENT IN THE LEFT COMMON ILIAC ARTERY FOR AORTOILIAC OCCLUSIVE DISEASE USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). IT WAS REPORTED WHILE THE PHYSICIAN WAS ADVANCING THE VBX DEVICE USING AN 8F SHEATH, RESISTANCE WAS MET DUE TO EXTENSIVE CALCIFICATION THROUGHOUT THE LEFT ILIAC ARTERY SYSTEM. REPORTEDLY, THE VBX DEVICE REACHED THE TARGET TREATMENT ZONE. HOWEVER, WHILE ADJUSTING THE STENT GRAFT, IT BECAME DISLODGED FROM THE BALLOON CATHETER. A SECOND BALLOON CATHETER WAS ADVANCED TO ASSIST WITH DEVICE EXPANSION. THE VBX DEVICE WAS SUCCESSFULLY IMPLANTED. THE PHYSICIAN SUSPECTS THE STENT GRAFT DISLODGED FROM THE BALLOON CATHETER DUE TO THE RESISTANCE DURING ADVANCEMENT FROM THE EXTENSIVE CALCIFICATION IN THE ILIAC SYSTEM. NO IMPACT TO THE PATIENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16467976 ↗
  • MalfunctionDec 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ON (B)(6) 2020, THE PATIENT WAS BEING IMPLANTED WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) TO TREAT STENOSIS OF THE BRACHIOCEPHALIC ARTERY. AN 8 FR SILK ROAD SHEATH WAS USED DURING THE PROCEDURE. IT WAS REPORTED THE VBX WAS ADVANCED AND IMPLANTED WITH NO ISSUE. HOWEVER, DURING WITHDRAWAL OF THE CATHETER RESISTANCE WAS MET. THE CATHETER WAS ABLE TO BE WITHDRAWN THROUGH THE SHEATH. IT WAS NOTED THE BALLOON HAD BECOME SEPARATED FROM THE CATHETER AND WAS LOCATED WITHIN THE PORTION OF THE SHEATH IN THE PATIENT. THE SHEATH AND BALLOON WERE SUCCESSFULLY WITHDRAWN FROM THE PATIENT TOGETHER. THE PATIENT TOLERATED THE PROCURED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 11098137 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160021. One submission often covers many models, so check the product and lot details in each record.

  • Z-0077-2022 · Sep 7, 2021 · Open, Classified
    Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diame

Other Iliac Covered Stent, Arterial devices

All Iliac Covered Stent, Arterial devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page