GORE VIABAHN VBX Balloon Expandable Endo BXAL083901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132637812), received between Dec 12, 2018 and May 4, 2023 — classified as 2 injuries, 1 malfunction.

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

• InjuryMay 4, 2023Malposition of Device; Malposition of Device

  ON (B)(6) 2023, THE PATIENT UNDERWENT BILATERAL TREATMENT IN THE COMMON ILIAC ARTERIES FOR OCCLUSION USING TWO 8 MM X 39 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. IT WAS REPORTED THE PHYSICIAN DEPLOYED BOTH DEVICES WITHOUT INCIDENT. REPORTEDLY, THE PHYSICIAN MISIDENTIFIED THE ORIGIN OF THE RIGHT HYPOGASTRIC ARTERY. IT WAS UNINTENTIONALLY FULLY COVERED DURING THE PROCEDURE. IT IS UNKNOWN WHICH VBX DEVICE WAS USED ON THE RIGHT SIDE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT; THEY WERE SENT HOME POST PROCEDURE AND NO FOLLOW UP NECESSARY. ADDITIONAL INFORMATION FOR SECOND DEVICE IS IN H8 / H9 / H10 / H11 ADDITIONAL MANUFACTURER NARRATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868396 ↗
• MalfunctionOct 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2022, A PATIENT PRESENTED FOR TREATMENT OF A STENOTIC BRACHIAL CEPHALIC ARTERY THAT WAS HEAVILY CALCIFIED. A CAROTID ARTERY CUT-DOWN WAS PERFORMED AND AN 8FR TERUMO PINNACLE SHEATH WAS PLACED. THROUGH THE 8FR SHEATH, AN 8LMM X 39MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INSERTED OVER A 0.035V STIFF WIRE. THE VBX DEVICE WAS DEPLOYED AT THE TREATMENT SITE. DURING WITHDRAWAL OF THE BALLOON CATHETER THROUGH THE SHEATH, RESISTANCE WAS FELT. WHEN THE CATHETER WAS REMOVED FROM THE SHEATH, IT WAS NOTICED THE DISTAL BALLOON COVER HAD INVERTED TOWARDS THE DEPLOYMENT HUB. ON THE BACK TABLE, THE SCRUB TECHNICIAN PULLED ON THE SIDE THAT WAS STILL ATTACHED, AND COMPLETELY DETACHED THE BALLOON COVER. AS REPORTED, THE SHEATH MAY HAVE CONTRIBUTED TO THE DETACHMENT OF THE BALLOON COVER WHILE CATHETER WAS BEING PULLED BACK THROUGH THE SHEATH. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617354 ↗
• InjuryDec 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF AN INNOMINATE ARTERY ULCERATED LESION WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. PLAQUE WAS PRESENT AT THE ORIGIN OF THE ARTERY. THE DEVICE WAS MODIFIED PRIOR TO INSERTION INTO THE PATIENT BY PARTIALLY DEPLOYING THE DEVICE TO REMOVE IT FROM THE BALLOON, THEN RELOADING IT ONTO AN ATLAS BALLOON, (16MM X 40MM). THIS DEVICE WAS THEN BACK FED THROUGH A 10 FR. BOSTON SCIENTIFIC SUPER SHEATH. THE COMMON CAROTID ARTERY WAS EXPOSED AND CLAMPED. THE PRE-SHEATHED DEVICE WAS THEN INSERTED THROUGH A 14 FR. GORE® DRYSEAL FLEX SHEATH. IT WAS ADVANCED UP TO THE AORTA, TOWARD THE TARGET LESION, BUT IT WAS NOTED THE BALLOON WAS NOT CENTERED. THIS DEVICE WAS THEN SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENT. IT WAS THEN RELOADED ONTO THE ATLAS BALLOON AND ADVANCED AGAIN. DEPLOYMENT WAS SUCCESSFUL, ALTHOUGH THE DEVICE ACCORDIONED IN THE CENTER. THIS LED TO SHORTENING OF THE DEVICE. IN ORDER TO COMPLETE THE TREATMENT LENGTH, ANOTHER VBX DEVICE WAS MODIFIED AND ADVANCED, BUT IT CAME OFF THE BALLOON AND EMBOLIZED ALL THE WAY DOWN TO THE LEFT COMMON FEMORAL ARTERY WHERE IT WAS SUCCESS

  Patient problems: Stroke/CVA

  MAUDE report 8158420 ↗

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