GORE VIABAHN VBX Balloon Expandable Endo BXA071901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132637249), received between Oct 11, 2018 and Oct 11, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED IN A PATIENT DURING AN ABDOMINAL AORTA ANEURYSM PROCEDURE. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE ALSO IMPLANTED DURING THIS TREATMENT. TWO VIABAHN VBX DEVICES WITH OVERLAP, WERE IMPLANTED IN THE RIGHT RENAL ARTERY AND ONE VIABAHN VBX DEVICE WAS IMPLANTED IN THE CELIAC ARTERY. DURING FOLLOW-UP ON (B)(6), THE PATIENT EXHIBITED SEVERE ALLERGIC REACTION AND HAD A SWOLLEN ABDOMEN. IT WAS REPORTED THAT HEPARIN WERE ADMINISTERED DURING THE IMPLANT PROCEDURE AND ONE DAY POST-IMPLANT. IN ADDITION, PATIENT HAD A KNOWN HISTORY OF ALPHA-GAL ALLERGY. AS REPORTED, PHYSICIANS ARE TAKING A CONSERVATIVE COURSE OF ACTION SINCE THE PATIENT IS REPORTED AS STABLE. THE PATIENT IS CURRENTLY BEING TREATED WITH MEDICATIONS, SUCH AS XOLAIR OR OTHER ANTIHISTAMINE.

  Patient problems: No Code Available; Renal Failure

  MAUDE report 7958830 ↗

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