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GORE VIABAHN VBX Balloon Expandable Endo BXA051902ARecalls & reported problems

W. L. Gore & Associates, Inc. · VIABAHN BX BALLOON EXP ENDO 5mmX19mm 7Fr 135cmCath 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132637096), received between Sep 16, 2019 and Sep 16, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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

  • Device Dislodged or Dislocated1
  • Patient-Device Incompatibility1

Patient problems

  • Aneurysm1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 16, 2019Patient-Device Incompatibility; Device Dislodged or Dislocated; Patient-Device Incompatibility; Device Dislodged or Dislocated

    THE FSA REPORTED THE FOLLOWING: THE PATIENT PRESENTED FOR ENDOVASCULAR REPAIR. ACCORDING TO THE DOCTOR, THE TARGET LOCATION FOR THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS THE LEFT RENAL WITH A TIGHT ORIFICE. THE DOCTOR MANUALLY 'SHAPED' THE VBX DEVICE BEFORE PUTTING IT ONTO THE WIRE. THE DOCTOR PROCEEDED TO ADVANCE THE VBX DEVICE THROUGH A SHORT 7FR TERUMO SHEATH FROM THE GROIN TO THE LEFT RENAL. THE DOCTOR WAS UNABLE TO CANNULATED THE RENAL SO ATTEMPTED TO WITHDRAW THE VBX DEVICE BACK INTO THE SHEATH. DURING THE ATTEMPTED WITHDRAWAL, THE DEVICE DISLODGED FROM THE BALLOON BUT WAS STILL ON THE WIRE. THE DOCTOR SUCCESSFULLY USED THE DISLODGED VBX DEVICE TO TREAT A DIFFERENT LESION IN THE EXTERNAL ILIAC. THE PATIENT IS FINE.

    Patient problems: Aneurysm

    MAUDE report 9073696 ↗

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