BIB® 614440Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964900174), received between Oct 11, 2022 and Oct 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K050857, K160889); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 11, 2022Break; Break

  AS PER THE REPORT FROM THE USER FACILITY / FOREIGN DISTRIBUTOR - WE HAVE BEEN REPORTER FROM THE HOSPITAL OF BERN A PROBLEM WITH THE REFERENCE (B)(4). APPARENTLY THE OUTER BALLOON EXPLODED AT 2 BAR, THIS CAUSED PROBLEMS IN THE REMOVAL OF THE BALLOON. FORTUNATELY THE PROCEDURE COULD BE TERMINATED WITHOUT CONSEQUENCES. WE ARE TRYING TO GET MORE INFORMATION ON THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579712 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050857, K160889. One submission often covers many models, so check the product and lot details in each record.

• Z-1754-2025 · Apr 21, 2025 · Terminated
  BIB Balloon in Balloon Dilatation Catheter. Model Number: 420