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DAR 350S19006Recalls & reported problems

Covidien LP · Electrostatic Filter Small, Angled Port · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 40884522012981), received between Aug 8, 2018 and Aug 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (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. Apr 29, 2021Open, Classified

    The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

    Z-1866-2021 · Root cause: Material/Component Contamination · FDA record ↗

Most reported problems

Device problems

  • Contamination of Device Ingredient or Reagent1
  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionAug 8, 2018Contamination of Device Ingredient or Reagent; Device Contamination with Chemical or Other Material; Contamination of Device Ingredient or Reagent

    ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD VISIBLE BLACK SPOT SEEN WITH FILTER. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 7763717 ↗

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.