Recall Information
FDA

Stellar non-invasive (air pushed through a mask or mouthpiece) and invasive (air pushed through a tube into the windpipe) ventilators are used to provide breathing support to adult and pediatric patients who are non-ventilator dependent and spontaneously breathing. These devices are used in hospitals, homes, or for mobile use with wheelchairs.

Reason for Recall: ResMed is recalling Stellar ventilators because the sound alarm may fail to work if:

• the device has a failed electronic part,
• the device is stored without AC power connected for more than 36 hours letting the battery drain completely, or
• the device powers on automatically when connected to AC power without pressing the power switch.

The use of affected Stellar ventilators may cause serious adverse health consequences, including risk of serious injury or death.

There has been one reported death.

For more information, visit FDA: https://www.fda.gov/medical-devices/medical-device-recalls/resmed-recalls-stellar-100-and-150-non-invasive-and-invasive-ventilators-due-sound-alarm-failure?utm_campaign=FDA%20MedWatch%20Stellar%20100%20and%20150%20Non-invasive%20and%20Invasive%20Ventilators%20by%20ResMed&utm_medium=email&utm_source=Eloqua