DAR 352/5855Recalls & reported problems

Covidien LP · Adult-Pediatric Electrostatic Filter HME with Catheter Mount Small · Class 2

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884522028103), received between Aug 22, 2023 and Aug 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 reports).

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

Disconnection2

Patient problems

Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 22, 2023Disconnection; Disconnection
ACCORDING TO THE REPORTER, THE CATHETER MOUNT HAD SPONTANEOUSLY DISCONNECTED. THERE WAS NO DAMAGE OR MALFORMATION TO THE CATHETER WAS NOTICED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 17599069 ↗
MalfunctionAug 22, 2023Disconnection; Disconnection
ACCORDING TO THE REPORTER, DURING NORMAL USE ON A VENTILATED PATIENT WITH A TRACHEOSTOMY CANNULA THE CATHETER MOUNT HAD SPONTANEOUSLY DISCONNECTED FROM THE PATIENT AND TRIGGERED VENTILATION DISCONNECTION ALARM, THE PATIENT WAS IMMEDIATELY RECONNECTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17599046 ↗

Device details

UDI-DI	`10884522028103`
Brand	DAR
Model	352/5855
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	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Apr 8, 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.

Other Filter, bacterial, breathing-circuit devices

VOCSN V+Pro, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
1 recall570 reports
VOCSN V+Pro Emergency, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
558 reports
VOCSN V+O+C+S+N+Pro, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
3 recalls366 reports
VOCSN V+Pro, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
2 recalls2 deaths325 reports
VOCSN V+C+S+N+Pro, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
185 reports
GIBECK IPN043751
Teleflex Incorporated · Filter, bacterial, breathing-circuit
2 recalls7 reports
VOCSN VOCSN, English
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
1 death96 reports
VOCSN V+C+Pro, Japanese
Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
1 recall33 reports

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.