DAR 355U5430Recalls & reported problems

Covidien LP · Infant-Pediatric Electrostatic Filter HME,Small · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884522038628), received between Jun 29, 2024 and Jun 29, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Split, Cut or Torn1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionJun 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WERE MANY "BURRS" OR EXCESS PARTS ON THE INNER SIDE OF THE ARTIFICIAL NOSE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19640437 ↗

Device details

UDI-DI	`20884522038628`
Brand	DAR
Model	355U5430
Company	Covidien LP
Product code	CAH · Filter, bacterial, breathing-circuit
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Apr 7, 2026

Device type (GMDN): Heat/moisture exchanger/microbial medical gas filter

A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.

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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.