Single Use Combination Cleaning Brush BW-411BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170297410), received between Apr 16, 2024 and Oct 11, 2024 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE SINGLE USE SINGLE-ENDED CLEANING BRUSH REPROCESSING WAS DEVIATED FROM THE REPROCESSING GUIDELINES. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433557 ↗
• MalfunctionApr 16, 2024Break; Failure to Clean Adequately; Break; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SINGLE USE COMBINATION CLEANING BRUSH TIP FELL OFF, A BROKEN BRUSH THAT WAS STUCK WITHIN THE BRONCHOVIDEOSCOPE'S CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116541 ↗