GORE VIABAHN VBX Balloon Expandable Endo BXBL085902ARecalls & reported problems
W. L. Gore & Associates, Inc. · BX2 HEP REDUCED PROFILE BX2 8MMX59MM 8Fr 135CM Cath · Class 3 · Implant
All models of GORE VIABAHN VBX Balloon Expandable Endo (111)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132658558), received between Dec 16, 2025 and Dec 16, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jul 1, 2024Class IIOpen, Classified
Due to packaging defects, sterility assurance and heparin activity may be compromised.
Z-2945-2024 · Root cause: Package design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Complete Blockage1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A COMPLEX AORTIC REINTERVENTION TO TREAT AN ENDOLEAK OF NON-GORE DEVICES. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE LEFT INTERNAL ILIAC ARTERY. REPORTEDLY, THE PHYSICIAN ATTEMPTED TO DELIVER THE VBX DEVICE TO THE LEFT INTERNAL ILIAC THROUGH AN 8.5 TOUR GUIDE INTRODUCER SHEATH WHICH HE BELIEVES WAS TOO SHORT IN LENGTH. DURING MANIPULATION OF THE VBX DEVICE, IT GOT CAUGHT ON THE PREVIOUSLY PLACED DEVICES AND DISLODGED. THE VBX DEVICE WAS RETRIEVED WITH A SNARE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW VBX DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824174 ↗InjuryDec 16, 2025Complete Blockage; Complete Blockage
ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF THE INFRARENAL AORTA FOR AORTOILIAC OCCLUSIVE DISEASE (AIOD) AND WAS IMPLANTED WITH AN AORTIC DEVICE AND TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 1 HOUR POST IMPLANT THE PATIENT BEGAN TO EXHIBIT SYMPTOMS AND THE PHYSICIAN DETERMINED ALL THREE DEVICES WERE OCCLUDED. THE PATIENT UNDERWENT A THROMBECTOMY AND IT WAS DETERMINED THAT THE PATIENT HAD DEVELOPED RHABDOMYOLYSIS. THE PATIENT TOLERATED THE PROCEDURE HOWEVER IT IS BELIEVED THAT THE PATIENT MAY REQUIRE AMPUTATION.
Patient problems: Thrombosis/Thrombus
MAUDE report 23818440 ↗
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 · each recall links to the FDA recall notice
- 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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