GORE VIABAHN VBX Balloon Expandable Endo BXA103902ARecalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN BX BALLOON EXP ENDO 10mmX39mm 8Fr135cmCath 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 00733132637393), received between Jun 4, 2026 and Jun 4, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (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.
Reports received per month
Most reported problems
Device problems
- Premature Activation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2026Premature Activation
ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AN UNKNOWN ETIOLOGY WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED IN THE LEFT ILIAC ARTERY AS ENDO TRASH AS IT WAS MEANT TO BE IMPLANTED IN THE RIGHT ILIAC ARTERY. DURING THE PROCEDURE, THE VBX DEVICE WAS ENTERED INTO THE LEFT SIDE AND WAS GOING OVER THE BIFURCATION TO BE PLACED IN THE INTENDED TREATMENT AREA WHEN THE VBX ENDOPROSTHESIS DISLODGED IN THE LEFT ILIAC ARTERY. THE DISLODGED VBX ENDOPROSTHESIS WAS LEFT AS ENDO TRASH AND THE PROCEDURE WAS COMPLETED BY IMPLANTING A NEW VBX DEVICE IN THE RIGHT ILIAC ARTERY. THE PATIENT IS DOING WELL.
Patient problems: Foreign Body In Patient
MAUDE report 25401247 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page