Federal regulators have told patients who rely on two widely used home ventilators that a small internal component can fail without warning and shut therapy down, and that replacement parts are not available fast enough to fix every affected machine.
The U.S. Food and Drug Administration published an Early Alert on ResMed Astral ventilators on July 15, covering Astral 100 and Astral 150 devices built before October 2024. These are not sleep apnea machines. They are life-sustaining ventilators used at home, in hospitals, and in portable settings by people who cannot reliably breathe on their own, including patients weighing more than 5 kilograms.