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DAR 352U5805Recalls & reported problems

Covidien LP · Adult Electrostatic Filter HME Large · 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 20884522037454), received between Nov 12, 2019 and Nov 12, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Misassembled” (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

  • Appropriate Device Problem Term/Code Not Available1
  • Misassembled1

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.

  • InjuryNov 12, 2019Misassembled; Appropriate Device Problem Term/Code Not Available; Misassembled; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE REPORTER, DURING USE, THE PEDIATRIC PATIENTS HAD BEEN BROUGHT IN TO THE INTENSIVE CARE UNIT WITH HYPOXIA AND HYPERCARBIA. THE PHYSICIAN STATED THAT THE FILTER AND VENT CIRCUITS THAT WERE BEING USED WAS NOT THE CORRECT SIZES. IT WAS INDICATED THAT THEY ARE USING A FILTER ADULT/PEDIATRICS LARGE FOR ALL POPULATIONS.

    Patient problems: Low Oxygen Saturation

    MAUDE report 9313479 ↗

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.