GORE VIABAHN VBX Balloon Expandable Endo BXB051902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132658282), received between Jun 20, 2025 and Dec 16, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 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 ON A SEVERELY STENOSED BARE METAL STENT IN THE RENAL ARTERY WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). REPORTEDLY, THE RENAL ARTERY WAS SEVERELY CALCIFIED (THE LUMEN MEASURED 4.6 IN DIAMETER) AND WAS A STEEP ANGLE ALONG WITH THE PREVIOUSLY FLARED BARE METAL STENT INTO AORTA MADE REENTRY DIFFICULT. THE PHYSICIAN GAINED ACCESS FROM THE RIGHT FEMORAL ARTERY WITH A 7FR PINNACLE INTRODUCER SHEATH, OVER AN 0.035" ROSEN WIRE. WHEN THE PHYSICIAN HAD RENAL ACCESS AND WERE READY TO ADVANCE THE STENT INTO THE RENAL FROM BELOW, THE SHEATH CAME BACK, AND THE STENT CAME OUT OF THE SHEATH WHILE TRYING TO GET INTO THE VESSEL. WHEN THE SHEATH CAME BACK, THE PHYSICIAN ATTEMPTED TO PULL BACK THE VBX DEVICE INTO THE SHEATH IN ORDER TO BETTER PARK THE 7FR SHEATH. THIS IS WHEN HE REALIZED THE STENT HAD COME OFF. THE PHYSICIAN GAINED ACCESS FROM THE OTHER FEMORAL ARTERY WITH AN 8FR SHEATH AND USED AN EN SNARE DEVICE TO CAPTURE THE STENT AND PULL INTO SHEATH TO REMOVE THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW VBX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824157 ↗
• MalfunctionJun 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, THE PATIENT HAD A PHYSICIAN-MODIFIED ENDOVASCULAR GRAFT PROCEDURE FOR AN ANEURYSM WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED IN THE RENAL ARTERY. A MEDTRONIC DEVICE WAS LASER FENESTRATED AND USED AS THE MAIN AORTIC COMPONENT IN THE CASE. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT USING AN 8F MEDTRONIC TOURGUIDE STEERABLE SHEATH OVER AN .035" TERUMO GLIDEWIRE GUIDEWIRE. REPORTEDLY, THE VBX DEVICE DELIVERY CATHETER ADVANCED THROUGH THE SHEATH TO THE TARGET LANDING ZONE WITHOUT RESISTANCE. THE DELIVERY CATHETER EXITED THE SHEATH AND THE ENDOPROSTHESIS WAS NO LONGER MOUNTED ON THE BALLOON. IT APPEARED THE ENDOPROSTHESIS DISLODGED INSIDE THE SHEATH SOMEWHERE BETWEEN THE HUB AND THE MIDDLE OF THE SHEATH. THE DELIVERY CATHETER WAS WITHDRAWN THROUGH THE SHEATH FROM THE PATIENT. A BALLOON WAS ADVANCED AND SLIGHTLY INFLATED, AND THE ENDOPROSTHESIS WAS PULLED OUT OF THE SHEATH. IT WAS REPORTED THE REASONS FOR THE STENT DISLODGEMENT WAS UNKNOWN. REPORTEDLY, THE ANATOMY WAS NOT TORTUOUS. ANOTHER VBX DEVICE WAS USED WITH THE SAME SHEATH TO COMPLETE THE PROCEDURE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302134 ↗

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