AirLife™ 6800-503Recalls & reported problems
Airlife · AirLife™ Isothermal Breathing Circuit 1.3 m (4.5') • Infant Respiratory Circuit Non-Heated · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752157408), received between Nov 20, 2022 and Jul 17, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Disconnect” (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
- Failure to Disconnect2
Patient problems
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2023Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AIRLIFE INFANT NON-HEATED CIRCUITS (6800-503) ARE DEFECTIVE. THE WATER TRAP OF THE SAID PRODUCTS, WAS HARDER TO REMOVE THAN USUAL .THE REPORTED INCIDENT DID NOT HAPPEN DURING PATIENT USE BUT ONE OF THE RESPIRATORY THERAPIST AT NICU DEPARTMENT HAD MINOR LACERATIONS WHEN THE WATER TRAP BROKE WHILE HE WAS OPENING IT.
Patient problems: Laceration(s)
MAUDE report 17331012 ↗InjuryNov 20, 2022Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE WATER TRAP WAS DIFFICULT TO REMOVE FROM THE 6800-503 CIRCUIT RESP INFANT 4FT UNHTD 30/CS. THE EVENT OCCURRED DURING USE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15831528 ↗
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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