GORE VIABAHN VBX Balloon Expandable Endo BXA095901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132637362), received between Oct 18, 2021 and Dec 9, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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.

• MalfunctionDec 9, 2022Activation Failure; Activation Failure

  ON (B)(6) 2022, THE PATIENT UNDERWENT A TIPS REDUCTION PROCEDURE USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE DISTAL END OF THE VBX DEVICE WAS UNSHEATHED AND THE BALLOON WAS INFLATED TO EXPAND THE DISTAL PORTION INSIDE PREVIOUSLY IMPLANTED VIATORR STENT. THE PHYSICIAN THEN DEFLATED THE BALLOON AND ATTEMPTED TO PULL THE BALLOON BACK TO COMPLETE THE REMAINING PORTION OF THE PARTIALLY DEPLOYED VBX DEVICE. HOWEVER, IT WAS REPORTED THE DELIVERY SYSTEM CATHETER BECAME STUCK ON THE GUIDEWIRE (AMPLATZ WIRE). THE PHYSICIAN DISCONNECTED THE HUB FROM THE CATHETER TRYING TO REMOVE THE DELIVERY SYSTEM FROM PATIENT. THE PHYSICIAN THEN PULLED THE GUIDEWIRE AND DELIVERY SYSTEM CATHETER OUT OF THE PATIENT. THE STENT GRAFT DISLODGED FROM THE DELIVERY SYSTEM CATHETER AND REMAINED IN ITS INTENDED LOCATION PARTIALLY DEPLOYED. THE PHYSICIAN THEN ADVANCE A GUIDEWIRE INTO THE PARTIALLY DEPLOYED VBX DEVICE. THE PROCEDURE WAS COMPLETE BY ADVANCING A BALLOON AND EXPANDING THE PARTIALLY DEPLOYED VBX DEVICE. THE DEVICE WAS REPORTEDLY ABLE TO BE FULLY EXPANDED IN ITS INTENDED LOCATION. NO PATIENT HARM OR IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955713 ↗
• InjuryOct 18, 2021Malposition of Device; Premature Separation; Malposition of Device; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT PRESENTED WITH STENOSIS IN THE RIGHT EXTERNAL ILIAC ARTERY AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE. THE PHYSICIAN WAS USING AN 8FR TERUMO SHEATH TO ADVANCE THE VBX DEVICE. AFTER EXITING THE SHEATH, WHICH REPORTEDLY HAD NO OBSERVABLE KINKS AT TIME OF INSERTION, THE PHYSICIAN NOTICED THE VBX DEVICE HAD BECOME DISLODGED FROM THE DELIVERY CATHETER. THE PHYSICIAN THEN DEPLOYED THE DISLODGED VBX DEVICE IN THE RIGHT EXTERNAL ILIAC ARTERY, WHICH REPORTEDLY RESULTED IN UNINTENTIONAL COVERAGE OF THE RIGHT INTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE AND THERE WAS NO PATIENT SEQUELAE FROM THE EVENT. THE PHYSICIAN HAD NO SPECULATION ON WHAT COULD HAVE CAUSED THE VBX DEVICE DISLODGEMENT. THE DELIVERY SYSTEM WILL BE RETURNED TO GORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647751 ↗

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