N/A 1745030Recalls & reported problems

Intersurgical Incorporated · HYDRO-GUARD MINI FILTER/HME · 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 05030267094462), received between Aug 2, 2018 and Aug 2, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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

Device Damaged by Another Device1
Obstruction of Flow1

Patient problems

No Information1

Recent adverse event reports

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

InjuryAug 2, 2018Obstruction of Flow; Device Damaged by Another Device
PRODUCT WAS CAUSING PROBLEM WITH VENTILATOR.
Patient problems: No Information
MAUDE report 7742777 ↗

Device details

UDI-DI	`05030267094462`
Brand	N/A
Model	1745030
Company	Intersurgical Incorporated
Product code	CAH · Filter, Bacterial, Breathing-Circuit
Class	Class 2
FDA submission	K092409
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 11, 2025

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.