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GORE VIABAHN VBX Balloon Expandable Endo BXA063901ARecalls & reported problems

W. L. Gore & Associates, Inc. · VIABAHN BX BALLOON EXP ENDO 6mmX39mm 7Fr 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
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 00733132637188), received between Sep 30, 2022 and Sep 30, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1
  • Separation Problem1

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 30, 2022Material Separation; Separation Problem; Material Separation; Separation Problem

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, A VBX DEVICE WAS INTENDED FOR USE IN THE RENAL ARTERY AS A PHYSICIAN MODIFIED GRAFT DURING TREATMENT OF AN AORTIC ANEURYSM. AFTER GAINING ACCESS THROUGH THE GROIN, THE PHYSICIAN ADVANCED THE VBX DEVICE THROUGH A 7FR TOUR GUIDE SHEATH, OVER A 0.035" GUIDE WIRE (MANUFACTURER UNKNOWN) AND THE VBX DEVICE WAS SUCCESSFULLY DELIVERED INTO THE RENAL ARTERY AS A PHYSICIAN MODIFIED GRAFT THROUGH A COOK AORTIC DEVICE. UPON REMOVAL OF THE DELIVERY CATHETER, IT WAS NOTICED THE DISTAL BALLOON COVER HAD BECOME DETACHED ON ONE SIDE AND APPEARED TO BE INVERTED. AN ANGIOGRAM WAS PERFORMED AND DEVICE VERIFIED TO BE IN PLACE WITH FULL EXPANSION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. 2203-A:-OTHER (BALLOON COVER DETACHED DURING CATHETER WITHDRAWAL).

    Patient problems: Aneurysm

    MAUDE report 15513457 ↗

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

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Sources and updates

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