AirLife™ 002002Recalls & reported problems
Vyaire Medical, Inc. · AirLife™ Nebulizer with Air Entrainment · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10190752144798), received between Jul 8, 2021 and May 15, 2024 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 reports).
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
Most reported problems
Device problems
- Leak/Splash3
- Complete Blockage1
- Insufficient Flow or Under Infusion1
- Moisture or Humidity Problem1
- Partial Blockage1
- Restricted Flow rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Distress1
- Irritability1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2024Partial Blockage; Complete Blockage; Restricted Flow rate; Insufficient Flow or Under Infusion; Partial Blockage; Complete Blockage; Restricted Flow rate; Insufficient Flow or Under Infusion
IT WAS REPORTED, THE FIRST CONCENTRATOR SHUT DOWN AND THE CONCENTRATOR AND BOTTLE WERE REPLACED. THE "SECOND CONCENTRATOR SHUTDOWN. "THROUGH THE NIGHT ANOTHER CONCENTRATOR AND BOTTLE [WERE] REPLACED, IN THE MORNING, YET ANOTHER ONE." IT WAS ADDITIONALLY REPORTED, THE INCIDENT OCCURRED DURING SETUP AT THE PATIENT BEDSIDE AND THE PATIENT EXHIBITED DISTRESS AND AGITATION; HOWEVER, THERE WAS NO REPORTED INJURY.
Patient problems: Distress; Irritability
MAUDE report 19326333 ↗MalfunctionAug 3, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE NEBULIZER WITH AIR ENTRAINMENT IS LEAKING A LOT OF WATER DURING PATIENT USE. THERE IS STILL GOOD AEROSOL OUTPUT TO THE PATIENT. THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17455436 ↗MalfunctionAug 3, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE NEBULIZER WITH AIR ENTRAINMENT IS LEAKING A LOT OF WATER DURING PATIENT USE. THERE IS STILL GOOD AEROSOL OUTPUT TO THE PATIENT. THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17455431 ↗MalfunctionAug 2, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE NEBULIZER WITH AIR ENTRAINMENT IS LEAKING. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17443216 ↗InjuryJul 8, 2021Moisture or Humidity Problem; Moisture or Humidity Problem
THE CUSTOMER REPORTED THAT THE 002002 NEBULIZER WITH AIR ENTRAINMENT FAILED TO DELIVER HIGH HUMIDITY FOR THE PATIENT WITH A TRACHEOSTOMY. THE PATIENT EXPERIENCED THICKENED SECRETIONS / WITH MUCOUS PLUG. THE PRODUCT WAS REPLACED WITH THE BACK UP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12139936 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.