GORE VIABAHN VBX Balloon Expandable Endo BXBL083902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132658572), received between Mar 12, 2025 and Mar 9, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A PHYSICIAN-MODIFIED ENDOGRAFT (PMEG) PROCEDURE USING A COOK ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT AS THE MAIN AORTIC COMPONENT. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR STENTING OF THE CELIAC ARTERY. DURING THE PROCEDURE, THE COOK 8F FLEXOR® ANSEL GUIDING SHEATH (55 CM) WAS UNABLE TO CROSS THE TARGET TREATMENT ZONE DUE TO TORTUOUS ANATOMY AND SUBOPTIMAL ALIGNMENT WITH THE GRAFT FENESTRATION. THE OPERATOR THEN ATTEMPTED TO ADVANCE THE VBX DELIVERY CATHETER ¿BAREBACK¿ OVER A COOK 0.035" ROSEN WIRE GUIDE (260 CM). RESISTANCE WAS ENCOUNTERED, AND ADVANCEMENT WAS HALTED. WHEN THE OPERATOR WITHDREW THE DELIVERY CATHETER BACK INTO THE INTRODUCER SHEATH, THE ENDOPROSTHESIS UNINTENTIONALLY DISLODGED FROM THE CATHETER AND ENTERED THE AORTA. A SNARE CATHETER WAS INTRODUCED AND SUCCESSFULLY USED TO RETRIEVE THE DISLODGED ENDOPROSTHESIS. THE OPERATOR SUBSEQUENTLY IMPLANTED A SECOND VBX DEVICE (8L MM × 39 MM), AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553441 ↗
• MalfunctionMar 12, 2025Separation Failure; Separation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE RENAL ARTERY DURING A PHYSICIAN-MODIFIED ENDOGRAFT (PMEG) PROCEDURE. AFTER A COOK ZENITH® FENESTRATED AAA ENDOVASCULAR GRAFT WAS DELIVERED, THE PHYSICIAN ATTEMPTED TO PLACE A VBX DEVICE IN THE RENAL ARTERY THROUGH AN 8.5FR OSCOR STEERABLE INTRODUCER SHEATH OVER AN 0.035" AMPLATZ WIRE. HOWEVER, DUE TO THE TORTUOSITY AND STENOSIS IN THE ARTERY, THE PHYSICIAN WAS UNABLE TO ADVANCE THE DEVICE INTO PLACE. AFTER MANIPULATING THE VBX DEVICE TRYING TO GET IT INTO POSITION, THE PHYSICIAN NOTICED THAT THE DEVICE STARTED TO COME OFF THE DELIVERY BALLOON. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE VBX DEVICE AND INTRODUCER SHEATH IN TANDEM THE VBX DEVICE HAD BECOME DISLODGED. THE PHYSICIAN WAS ABLE TO USE A SNARE AND REMOVE THE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588115 ↗

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