GORE VIABAHN VBX Balloon Expandable Endo BXB083901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132658718), received between Aug 29, 2025 and Aug 29, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

Recalls naming this device

1. 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: DURING AN ILIAC ARTERY TREATMENT, A COMMON FEMORAL ENDARTERECTOMY WAS PERFORMED FIRST. AS REPORTED, THE COMMON ILIAC ARTERY AND EXTERNAL ILIAC ARTERY WERE EXTREMELY CALCIFIED. AFTER THE COMPLETION OF ENDARTERECTOMY, A 7FR X 10CM SHEATH (UNSPECIFIED BRAND) WAS USED TO ADVANCE AN 8X39 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). AT THIS TIME, IT WAS REALIZED THE LENGTH OF THE VBX DEVICE WAS INADEQUATE. THE PHYSICIAN PULLED THE VBX DEVICE BACK FROM THE COMMON ILIAC ARTERY AND OUT OF THE SHEATH. WHEN DEVICE WAS REMOVED, THE VBX STENT WAS MISSING. UNDER FLUOROSCOPY, THE DISLODGED VBX STENT WAS FOUND IN THE EXTERNAL ILIAC ARTERY. THE VBX BALLOON CATHETER WAS RE-INSERTED AND THE VBX BALLOON EASILY SLID BACK INTO THE VBX STENT THAT WAS STILL ON THE WIRE. AFTER MOVING THE VBX STENT NEAR THE TARGET TREATMENT ZONE, IT WAS DEPLOYED. THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF ONE ADDITIONAL VBX DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. IT WAS REPORTED TWO SAME-SIZED VBX DEVICES WERE USED DURING THIS PROCEDURE, AND IT IS UNKNOWN WHICH VBX DEVICE HAD THE DISLODGEMENT ISSUE. THE PHYSICIAN STATED THE VBX STENT MAY HAV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22927205 ↗

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