Ventlab AF2142MC-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483081181), received between Sep 12, 2025 and Sep 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 11, 2023Open, Classified

   A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

   Z-0361-2024 · Root cause: Device Design · FDA record ↗

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.

• MalfunctionSep 12, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED: AIR WAS NOT FLOWING THROUGH THE BAG, THE RESPIRATORY THERAPIST (RT) PUT WATER INTO [THE BAG] TO TEST IT; WATER LEAKED OUT OF THE LOWER PORTION OF THE BAG. THIS RESULTED IN DELAY IN TREATMENT AS THEY HAD TO OPEN UP ANOTHER BAG; HOWEVER, THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23045531 ↗