Ventlab AF5000MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483073346), received between Apr 23, 2026 and Apr 23, 2026 — classified as 1 malfunction.

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

• MalfunctionApr 23, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A CODE BLUE EVENT, THE NURSE REMOVED THE BAG VALVE MASK (BVM) FROM THE CRASH CART AND FOUND IT BROKEN INTO MULTIPLE PIECES. THE REGISTERED NURSE HAD TO OBTAIN ANOTHER BVM, RESULTING IN A DELAY IN PATIENT CARE. DUE TO QUALITY ASSURANCE (QA) REQUIREMENTS, STAFF DO NOT WANT TO BREAK THE TAPED SEAL ON THE BAG. ADDITIONALLY, THE COLOR OF THE BAG PREVENTS VISUAL INSPECTION OF THE BVM, LIMITING THE ABILITY TO VERIFY THE DEVICE'S CONDITION DURING ROUTINE CRASH CART CHECKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975166 ↗