Vyntus V-378510Recalls & reported problems

Vyaire Medical, Inc. · Vyntus APS · Class 2

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 04250892904863), received between Aug 30, 2023 and Aug 30, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (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.

Most reported problems

Device problems

Computer Software Problem1

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.

MalfunctionAug 30, 2023Computer Software Problem; Computer Software Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT ON THE METHACHOLINE CHALLENGE TEST REPORTS, THAT IF THE RESULT IS NEGATIVE BUT THE PD20 IS REACHED IN THE "NORMAL" RANGE, THE SENTRYSUITE 3.20.3 SOFTWARE OF THE VYNTUS APS INCORRECTLY INTERPRETS THIS AS "MILD" POSITIVE ON THE SEVERITY INDICATOR BAR FOR AIRWAY HYPERRESPONSIVENESS. DISPLAYED MEASUREMENT RESULTS ON THE REPORT ARE CORRECT. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17650879 ↗

Device details

UDI-DI	`04250892904863`
Brand	Vyntus
Model	V-378510
Company	Vyaire Medical, Inc.
Product code	BZC · CALCULATOR, PULMONARY FUNCTION DATA
Class	Class 2
FDA submission	K190853
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 24, 2025

Device type (GMDN): Therapeutic agent nebulizer, benchtop

An assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.

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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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