GORE VIABAHN VBX Balloon Expandable Endo BXB062901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132658411), received between Nov 13, 2024 and Oct 21, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACOABDOMINAL AORTIC ANEURYSM UTILIZING A PHYSICIAN-MODIFIED ENDOVASCULAR GRAFT AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES (VBX DEVICES). THE PHYSICIAN GAINED ACCESS FROM THE RIGHT COMMON FEMORAL ARTERY WITH A 0.035" ROSEN GUIDE WIRE, THROUGH A BAYLISS PASSPORT 6.5FR STEERABLE SHEATH. AFTER REPEATED ATTEMPTS TO ADVANCE THE VBX DEVICE INTO THE CELIAC ARTERY, HE PULLED IT BACK AND THE STENT CAME OFF THE BALLOON AND REMAINED IN THE PATIENT. THE PHYSICIAN REMOVED THE VBX DEVICE WITH A TRI LOBE ENSNARE AND SUCCESSFULLY COMPLETED THE CASE WITH A NEW VBX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350271 ↗
• MalfunctionNov 13, 2024Premature Separation; Premature Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE RIGHT RENAL ARTERY DURING A PHYSICIAN-MODIFIED ENDOGRAFT (PMEG) PROCEDURE TO TREAT AN AORTIC ANEURYSM. IT WAS REPORTED, ON AN UNKNOWN DATE THE PATIENT HAD BARE METAL STENTS (BMS; MANUFACTURER UNKNOWN) IMPLANTED INTO THE RIGHT AND LEFT RENAL ARTERIES. DURING THE PMEG PROCEDURE ON (B)(6) 2024, THE RIGHT RENAL ARTERY WAS SUCCESSFULLY STENTED WITH A VBX DEVICE WITHOUT ISSUE. THE PHYSICIAN THEN ATTEMPTED TO STENT THE LEFT RENAL ARTERY. HOWEVER, DURING THE ADVANCEMENT THOUGH THE BMS, THE VBX DEVICE HAD BECOME STUCK. AFTER MANIPULATING THE DEVICE, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE VBX DEVICE THROUGH THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN). AFTER THE VBX DEVICE WAS REMOVED, IT WAS OBSERVED TO HAVE BEEN DISPLACED ON THE DELIVERY CATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW VBX DEVICE, WHEN HE WAS MET WITH THE SAME RESISTANCE. AFTER SOME MANIPULATING, THE DELIVERY CATHETER WAS REMOVED, AND THE STENT HAD BECOME DISLODGED FROM THE DELIVER CATHETER. AN ANGIOGRAM WAS PERFORMED AND CONFIRMED THAT THE STENT WAS IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675067 ↗
• MalfunctionNov 13, 2024Premature Separation; Premature Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE RIGHT RENAL ARTERY DURING A PHYSICIAN-MODIFIED ENDOGRAFT (PMEG) PROCEDURE TO TREAT AN AORTIC ANEURYSM. IT WAS REPORTED, ON AN UNKNOWN DATE THE PATIENT HAD BARE METAL STENTS (BMS; MANUFACTURER UNKNOWN) IMPLANTED INTO THE RIGHT AND LEFT RENAL ARTERIES. DURING THE PMEG PROCEDURE ON (B)(6) 2024, THE RIGHT RENAL ARTERY WAS SUCCESSFULLY STENTED WITH A VBX DEVICE WITHOUT ISSUE. THE PHYSICIAN THEN ATTEMPTED TO STENT THE LEFT RENAL ARTERY. HOWEVER, DURING THE ADVANCEMENT THOUGH THE BMS, THE VBX DEVICE HAD BECOME STUCK. AFTER MANIPULATING THE DEVICE, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE VBX DEVICE THROUGH THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN). AFTER THE VBX DEVICE WAS REMOVED, IT WAS OBSERVED TO HAVE BEEN DISPLACED ON THE DELIVERY CATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW VBX DEVICE, WHEN HE WAS MET WITH THE SAME RESISTANCE. AFTER SOME MANIPULATING, THE DELIVERY CATHETER WAS REMOVED, AND THE STENT HAD BECOME DISLODGED FROM THE DELIVER CATHETER. AN ANGIOGRAM WAS PERFORMED AND CONFIRMED THAT THE STENT WAS IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674946 ↗

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