GORE VIABAHN VBX Balloon Expandable Endo BXA083901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132637300), received between Jun 16, 2020 and Jan 29, 2024 — classified as 3 injuries, 1 malfunction.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6), 2024, THE PATIENT UNDERWENT TREATMENT FOR LEFT LOWER EXTREMITY PAIN USING A 8 MM X 39 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) IN THE ILIAC ARTERY. IT WAS REPORTED THE PHYSICIAN ADVANCED THE DELIVERY CATHETER USING A 7F TERUMO INTRODUCER SHEATH OVER AN 0.035" GLIDEWIRE GUIDEWIRE TO THE TARGET TREATMENT SITE. REPORTEDLY, THE DEVICE ADVANCED TO THE DISTAL END OF THE SHEATH. HALF THE ENDOPROSTHESIS MADE IT OUT OF THE SHEATH, BUT IT WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN ATTEMPTED TO PULL THE ENDOPROSTHESIS BACK INTO THE SHEATH. THE ENDOPROSTHESIS ACCORDIONED, AND BECAME DISLODGED FROM THE CATHETER. THE CATHETER WAS WITHDRAWN FROM THE PATIENT. SURGICAL CUT DOWN WAS PERFORMED, AND THE ENDOPROSTHESIS WAS RETRIEVED AND REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER VBX DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT OTHER THAN THE SURGICAL CUT DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602890 ↗
• InjuryAug 3, 2023Positioning Problem; Positioning Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT TREATMENT IN THE CELIAC ARTERY FOR AN ANEURYSM USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. IT WAS REPORTED THE PHYSICIAN ACCESSED THE TREATMENT AREA USING AN 8F MEDTRONIC TOURGUIDE STEERABLE SHEATH OVER AN UNKNOWN BRAND AND SIZE GUIDEWIRE, WITH THE TABLE AT A LATERAL RAO ANGLE. REPORTEDLY, THE PHYSICIAN COULD SEE THE LANDING ZONE AND DECIDED TO DEPLOY THE DEVICE. THE ANEURYSM WAS COVERED. AT THIS TIME IT WAS UNKNOWN IF THE HEPATIC AND / OR SPLENIC ARTERIES HAS BEEN INFRINGED UPON. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS DONE ON AN UNKNOWN DATE AND TIME. THE CTA SHOWED THE SPLENIC AND HEPATIC ARTERIES BOTH HAD THROMBUS WITH DISRUPTION OF BLOOD FLOW. REPORTEDLY, THE PHYSICIAN SUSPECTS THE VBX DEVICE DID NOT DEPLOY WHERE HE ORIGINALLY LANDED, BUT THE SPLENIC AND HEPATIC VESSELS WERE NOT COVERED BY THE VBX DEVICE. A REINTERVENTION HAS NOT BEEN SCHEDULED AT THIS TIME. THE PATIENT IS BEING MONITORED.

  Patient problems: Reduced Blood Flow; Thrombosis/Thrombus

  MAUDE report 17452235 ↗
• InjuryNov 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE WAS INTENDED FOR USE IN THE ILIAC ARTERY. DURING THE ADVANCEMENT OF THE VBX DEVICE, THE PHYSICIAN WAS MET WITH RESISTANCE IN THE CALCIFIED LESION. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE VBX DEVICE, IT HAD BECOME DISLODGED IN THE CALCIFICATION. THE DECISION WAS MADE TREAT THE PATIENT WITH OPEN PROCEDURE. THE PHYSICIAN DIDN'T FEEL THIS WAS A GOOD PLACE LEAVE THE VBX DEVICE AND REMOVED IT WITH A SNARE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 12748748 ↗
• MalfunctionJun 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO GORE ON (B)(6) 2020 A PROCEDURE WAS BEING PERFORMED USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE PHYSICIAN REPORTED THE PATIENT HAD TORTUOUS ANATOMY WHICH HE BELIEVES CAUSED THE STENT TO FALL OFF THE BALLOON. HE THEN TRIED ANOTHER VBX OF THE SAME SIZE AND THAT STENT CAME OFF THE BALLOON AS WELL. PATIENT DISPOSITION IS UNKNOWN AT THIS TIME. THIS MEDWATCH REPORT IS FOR THE 1ST REPORTED DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10159890 ↗

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