GORE VIABAHN VBX Balloon Expandable Endo BXA103901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132637386), received between Mar 30, 2023 and Mar 30, 2023 — classified as 1 malfunction.

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

• MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE LEFT COMMON ILIAC ARTERY FOR HIGH-GRADE ILIAC STENOSIS. ACCESS WAS GAINED THROUGH THE BRACHIAL ARTERY, AND THE VBX DEVICE WAS ADVANCED THROUGH A 9FR INTRODUCER SHEATH (MANUFACTURER UNKNOWN). IT WAS NOTED, THE PATIENT HAD SEVERE ANGULATED ANATOMY, AND A PRE-EXISTING INFRARENAL AORTIC ENDOGRAFT (UNKNOWN MANUFACTURER/IMPLANT DATE). THE PHYSICIAN SUSPECTED THE PATIENT'S ANATOMY AND EXISTING ENDOGRAFT MAY HAVE CONTRIBUTED TO THE 10MMX39MM VBX DEVICE BECOMING DISLODGED. IMMEDIATELY, THE PHYSICIAN ATTEMPTED TO RETRIEVE THE VBX DEVICE UNSUCCESSFULLY WITH A SNARE ENDOVASCULARLY. CONSEQUENTLY, THE PHYSICIAN LEFT THE VBX DEVICE IN PLACE. ULTIMATELY, THE PHYSICIAN WAS ABLE TO PIN THE VBX DEVICE TO THE VESSEL WALL USING A BARE METAL STENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16645311 ↗

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