Infant Flow 777002SRecalls & reported problems

Vyaire Medical, Inc. · Infant Flow LP Nasal Mask - Small · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 10190752151963), received between Nov 6, 2023 and Nov 6, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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

Material Deformation1

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.

InjuryNov 6, 2023Material Deformation; Material Deformation
IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH INFANT FLOW LP NASAL MASK IN WHICH THE MASK AND PRONG KINKED, PREVENTING THE BABY FROM BREATHING. ATTEMPTS WERE MADE BY TIGHTENING OR LOOSENING SIDES, BIGGER AND SMALLER MASKS, BUT DID NOT HELP. FURTHERMORE, THERE WAS NOT PATIENT HARM REPORTED. THE PATIENT WAS TAKEN OFF CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) AND PUT ON THE HEATED MUSTACHE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18074555 ↗

Device details

UDI-DI	`10190752151963`
Brand	Infant Flow
Model	777002S
Company	Vyaire Medical, Inc.
Product code	BZD · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Class	Class 2
FDA submission	K031745
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	Mar 15, 2021

Device type (GMDN): CPAP/BPAP nasal mask, single-use

A non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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All VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices →

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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