AirLife 4681-504Recalls & reported problems
Carefusion Corporation · Airlife™ Isothermal™ Breathing Circuit Adult Inspiratory Line Heated · Class 2
All models of AirLife (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403039539), received between Dec 17, 2021 and Apr 14, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fire” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fire2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2022Fire; Fire
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 4681-504-INSPIRATORY LINE HTD 8FT ADULT 20/CS STARTED TO BURNED WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRM THAT THERE IS NO HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14116193 ↗MalfunctionDec 17, 2021Fire; Fire
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 4681-504-INSPIRATORY LINE HTD 8FT ADULT 20/CS STARTED TO FIRE WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRM THAT THERE IS NO HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13025437 ↗
Other HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER devices
- VOCSN V*Home, EnglishVentec Life Systems, Inc. · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer4 deaths318 reports
- F&P Evaqua 2 RT380Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer305 reports
- F&P Evaqua 2 RT265Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer114 reports
- F&P Evaqua 2 RT266Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer93 reports
- AirLife™ AH165Airlife · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall1 report
- AirLife™ AH165Airlife · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer1 recall0 reports
- HUDSON RCI IPN046879Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
- HUDSON RCI IPN046880Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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