GORE VIABAHN VBX Balloon Expandable Endo BXA097901ARecalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN BX BALLOON EXP ENDO 9mmX79mm 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
- 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 00733132637591), received between Sep 1, 2020 and Sep 1, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2020, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS TO BE DELIVERED FOR TREATMENT OF STENOSIS IN THE LEFT COMMON ILIAC. HOWEVER, WHEN THE PHYSICIAN WAS ADVANCING THE DEVICE OVER THE AORTIC BIFURCATION HE FELT RESISTANCE AND REMOVED THE DEVICE. THE PHYSICIAN WANTED TO PRE-BALLOON THE CALCIFICATION BEFORE FURTHER ADVANCING THE DEVICE. WHEN THE CATHETER WAS REMOVED IT WAS NOTICED THAT THE DEVICE HAD BECOME DISLODGED IN THE CALCIFICATION. THE PHYSICIAN ADVANCED A 2MM X 100MM (MANUFACTURER UNKNOWN) THROUGH THE DEVICE AND EXPANDED IT ENOUGH TO ADVANCE A 4MM X 100MM (MANUFACTURER UNKNOWN) BALLOON THROUGH THE DEVICE AND EXPANDED THE DEVICE ENOUGH TO GET THE ORIGINAL VBX CATHETER THROUGH THE DEVICE AND SUCCESSFULLY DEPLOYED THE DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10478527 ↗
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, ClassifiedHeparin, 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
- GORE VIABAHN VBX Balloon Expandable Endo BXB073902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall2 deaths19 reports
- iCast Covered Stent System, 6mmX16mmX120cm 42616Atrium Medical Corporation · Iliac Covered Stent, Arterial1 recall15 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB057902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall2 deaths14 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB067902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall14 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB075902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall11 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB095902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB077902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB085902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall2 deaths8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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