GORE VIABAHN VBX Balloon Expandable Endo BXA113901ARecalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN BX BALLOON EXP ENDO 11mmX39mm 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 00733132637713), received between Jul 13, 2021 and Jul 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed 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
- Difficult or Delayed Separation1
Patient problems
- Unspecified Vascular Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2021Difficult or Delayed Separation; Difficult or Delayed Separation
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE RENAL VEIN. AFTER THE VBX DEVICE WAS SUCCESSFULLY DELIVERED, THE PHYSICIAN WAS UNABLE TO FULLY DEFLATE THE DELIVERY BALLOON AFTER INFLATION TO THE NOMINAL PRESSURE OF 11ATM. THE PHYSICIAN WAS ALSO UNABLE TO REMOVE OR ADVANCE THE .035 ROSEN GUIDE WIRE THAT WAS USED FOR STENT DELIVERY. THE PHYSICIAN CUT THE HUB OFF OF THE DELIVERY CATHETER, ADVANCED A LONG 8FR SHEATH OVER THE BALLOON AND SUCCESSFULLY REMOVED THE DELIVERY CATHETER AND GUIDE WIRE. THERE WERE NO ADDITIONAL MEDICAL TREATMENTS NECESSARY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.
Patient problems: Unspecified Vascular Problem
MAUDE report 12162269 ↗
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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