GORE VIABAHN VBX Balloon Expandable Endo BXA062901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132637461), received between May 29, 2019 and Aug 29, 2019 — classified as 1 injury, 1 malfunction.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE DOCTOR REPORTED THE FOLLOWING TO THE GORE FSA: THE PATIENT PRESENTED FOR A MODIFIED FENESTRATED AORTIC CASE. AFTER THE FENESTRATION WAS CREATED AND THE WIRE PLACED IN THE RIGHT RENAL, THE DOCTOR WAS UNABLE TO ADVANCE THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX), USING A 7FR SHEATH, THROUGH THE FENESTRATED HOLE. THE DOCTOR PULLED THE VBX BACK INTO THE SHEATH AND OBSERVED THAT THE STENT HAD DISLODGED FROM THE BALLOON. THE DISLODGED STENT WAS JAILED ABOVE THE CELIAC ARTERY BEHIND THE TEVAR.

  Patient problems: Aneurysm

  MAUDE report 8946050 ↗
• InjuryMay 29, 2019Entrapment of Device; Entrapment of Device

  ADDITIONAL INFORMATION FROM THE PHYSICIAN WAS OBTAINED. THE BALLOON CATHETER MAY HAVE ENCOUNTERED AN OVATION AAA DEVICE STRUT, CAUSING DAMAGE TO THE VBX DEVICE DURING WITHDRAWAL. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (LOT #18674112) THAT WAS ADVANCED FROM THE ARM THROUGH THE 7FR COOK SHEATH WAS THE ONLY ONE THAT ENCOUNTERED ISSUES DURING THE WITHDRAWAL OF DELIVERY CATHETER. THE FOUR IMPLANTED VBX DEVICES HAD DIFFERENT ENTRY POINTS. THEY WERE NOT ALL ADVANCED FROM THE SAME ENTRY POINTS AS STATED IN ORIGINAL DESCRIPTION.

  Patient problems: Perforation

  MAUDE report 8651792 ↗

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