Vyaire V-892384Recalls & reported problems

Jaeger Medical GmbH · MicroGard II, bacterial/viral filter · 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 34250892903041), received between Oct 17, 2023 and Oct 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Insufficient Device Problem Information1

Patient problems

Cough1

Recent adverse event reports

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

MalfunctionOct 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO VYAIRE THE FOLLOWING INVOLVING THE MICROGARD FILTER: THE CUSTOMER COMPLAINED, THAT ALL PATIENTS TESTED ON THE REPORTED EVENT DATE KEPT MENTIONING THAT THEY FELT SOMETHING HITTING THE BACK OF THEIR THROAT WHENEVER THEY DID GAS TRANSFER. THE HEALTH PROFESSIONALS (B)(6) DECIDED TO TEST IT OUT BY THEMSELVES AND DID THEIR GAS TRANSFER A FEW TIMES USING DIFFERENT MICROGARD FILTERS. THEY FOUND THAT WITH MOST OF THEM, THEY FELT LIKE THEY WERE INHALING WHAT THEY DESCRIBED AS "SMALL FIBERS" LIKE YOU WOULD DO IN A DUSTY ENVIRONMENT. IT MADE THEM COUGH, GAG AND CHOKE AND THEY FELT THE EFFECTS OF IT FOR THE FOLLOWING COUPLE OF HOURS.
Patient problems: Cough
MAUDE report 17954122 ↗

Device details

UDI-DI	`34250892903041`
Brand	Vyaire
Model	V-892384
Company	Jaeger Medical GmbH
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	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 28, 2025

Device type (GMDN): Microbial medical gas filter, single-use

A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.