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DAR 351U5979Recalls & reported problems

Covidien LP · Mechanical Filter Small · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884522033319), received between Dec 15, 2020 and Dec 15, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Filtration Problem” (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

Device problems

  • Filtration Problem1

Patient problems

  • Low Oxygen Saturation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 15, 2020Filtration Problem; Filtration Problem

    ACCORDING TO THE REPORTER, AFTER PATIENT WAS EMERGING FROM ANESTHESIA, ETCO2 WAS LOST AND O2 SATURATION DROPPED PRECIPITOUSLY. IT WAS UNABLE TO MOVE GASES THROUGH FILTER DUE TO SUSPECTED CLOGGING WITH SECRETIONS.

    Patient problems: Low Oxygen Saturation

    MAUDE report 11012774 ↗

Other Filter, bacterial, breathing-circuit devices

All Filter, bacterial, breathing-circuit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.