ResMed issues correction for Astral ventilators due to electrical component failure risk

ResMed has released a correction for certain Astral ventilators after identifying a faulty electrical component that could interrupt therapy and cause serious injury or death.

The FDA classifies the recall as the most serious type, but the correction does not require removal of the devices; instead, replacement parts should be installed as soon as they become available.

Affected models include Astral 100 and 150 units built before October 2024, with specific serial numbers and UDIs listed. The company advises patients not to stop using the ventilators unless directed by a clinician.

ResMed has sent a letter to customers recommending prompt correction, and the devices continue to be used in home, hospital, and portable settings while awaiting the parts.