Jaeger V-892893Recalls & reported problems

Jaeger Medical GmbH · Disposable Mouthpiece, flex · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 04250892907383), received between Jun 25, 2025 and Jun 25, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Patient-Device Incompatibility1

Patient problems

Hypersensitivity/Allergic reaction1

Recent adverse event reports

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

MalfunctionJun 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT A CUSTOMER HAS CONCERNS ABOUT AN ALLERGIC REACTION OF A PATIENT IN ASSOCIATION WITH THE BLUE TIP OF THE MICROGARD FILTER. DESPITE REMINDERS, THE CUSTOMER DID NOT PROVIDED FURTHER INFORMATION.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 22326296 ↗

Device details

UDI-DI	`04250892907383`
Brand	Jaeger
Model	V-892893
Company	Jaeger Medical GmbH
Product code	BYP · Mouthpiece, Breathing
Class	Class 1
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	Jun 10, 2025

Device type (GMDN): Breathing mouthpiece, single-use

A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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