GORE VIABAHN VBX Balloon Expandable Endo BXBL082902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132658596), received between Apr 15, 2024 and Apr 15, 2024 — 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.

• MalfunctionApr 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A REDUCED PROFILE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED IN THE RENAL ARTERY WITH A COOK FENESTRATED AORTIC GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, THE PROCEDURE PRESENTED A CHALLENGE FOR THE PHYSICIAN WITH THE APPROACHED ANGLE ACCESSED FROM THE BRACHIAL ARTERY; THROUGH A COOK FENESTRATED AORTIC GRAFT; TO THE IMPLANT SITE OF THE RENAL ARTERY. THE VBX DEVICE WAS ADVANCED OVER A 0.035¿ TERUMO ADVANTAGE GLIDEWIRE THROUGH A 7.5 F DESTINO STEERABLE SHEATH WITHOUT DIFFICULTY. IT WAS NOTED THE INTRODUCER SHEATH WAS PARKED AT THE OPENING OF THE RENAL ARTERY AND THE VBX DEVICE WAS THEN ADVANCED ONLY ON THE GUIDEWIRE. THE PHYSICIAN NEEDED TO REPOSITION THE VBX DEVICE AND TO DO SO WITHDREW THE VBX DEVICE DELIVERY CATHETER BACK SLIGHTLY INTO THE INTRODUCER SHEATH. CONSEQUENTLY, THE VBX STENT GRAFT CAME OFF OF THE DELIVERY CATHETER AND DISLODGED. THE PHYSICIAN REPORTEDLY REMOVED THE VBX DEVICE DELIVERY CATHETER WITHOUT DIFFICULTY AND WAS ABLE TO USE A PTA BALLOON TO IMPLANT THE VBX STENT GRAFT WHERE IT DISLODGED. THERE WAS NO BRANCH VESSEL COVERAGE. AN ADDITIONAL REDUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19110641 ↗

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