GORE VIABAHN VBX Balloon Expandable Endo BXA052902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132637430), received between Dec 6, 2021 and May 27, 2022 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionMay 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: PATIENT PRESENTED FOR AN ENDOVASCULAR TREATMENT AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS PREPPED BY A TECHNICIAN PRIOR TO INSERTION OF VBX DEVICE. AS THE VBX DEVICE WAS ADVANCED TO THE INTENDED TREATMENT SITE, THE VBX STENT CAME OFF THE DELIVERY CATHETER. THE PHYSICIAN WAS ABLE TO SNARE AND REMOVE THE CONSTRAINED DEVICE WITH NO HARM TO PATIENT. A NEW VBX DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE TECHNICIAN MAY HAVE INADVERTENTLY PULLED TOO MUCH NEGATIVE PRESSURE ON THE BALLOON DURING PREP, WHICH MAY HAVE CONTRIBUTED TO THE STENT DISLODGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526672 ↗
• InjuryDec 6, 2021Inflation Problem; Inflation Problem

  THE FOLLOWING WAS REPORTED TO GORE: DURING A FOUR-VESSEL ENDOVASCULAR FENESTRATED AORTIC ANEURYSM REPAIR, TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE UTILIZED. THE VBX DEVICES WERE DEPLOYED IN THE RIGHT AND LEFT RENAL ARTERY. AS REPORTED, THE PHYSICIAN STATED THE RENAL ARTERIES WERE SMALL (LESS THAN 5MM) AND THE VBX BALLOONS WERE INFLATED TOO QUICKLY AND WERE EXPANDED TOO LARGE, BEYOND THE VESSEL SIZES. EXTRAVASATION WAS SEEN ON ANGIOGRAPHY. AS REPORTED, NEITHER ARTERY COULD NOT BE SAVED, RESULTING IN COVERAGE OF THE FENESTRATION. THE VBX DEVICES REMAIN IMPLANTED. AS REPORTED, THE PATIENT WAS RECOVERING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 12941352 ↗
• InjuryDec 6, 2021Inflation Problem; Inflation Problem

  THE FOLLOWING WAS REPORTED TO GORE: DURING A FOUR-VESSEL ENDOVASCULAR FENESTRATED AORTIC ANEURYSM REPAIR WITH A COOK AAA DEVICE, TWO 5MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE UTILIZED. THE VBX DEVICES WERE DEPLOYED IN THE RIGHT AND LEFT RENAL ARTERY. AS REPORTED, THE PHYSICIAN STATED THE RENAL ARTERIES WERE SMALL (APPROXIMATELY 4MM) AND THE VBX BALLOONS WERE INFLATED TOO QUICKLY AND WERE EXPANDED TOO LARGE FOR THE VESSEL SIZES. EXTRAVASATION WAS SEEN ON ANGIOGRAPHY. THE PHYSICIAN ATTEMPTED TO SALVAGE THE ARTERIES BY GAINING WIRE ACCESS TO VISCERAL VESSELS. HOWEVER, NEITHER ARTERY COULD NOT BE SAVED, RESULTING IN COVERAGE OF THE FENESTRATION. THE VBX DEVICES REMAIN IMPLANTED. THE PATIENT WAS REPORTED TO BE RECOVERING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 12941248 ↗

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