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.
The practical consequence for households is unusual, and it is the reason this alert matters more than a routine device notice. Regulators are not telling patients to stop using the devices. They are telling patients to keep using them while confirming that a working backup is within reach, because the supply of replacement circuit boards is limited and corrections are being rationed by clinical risk.
"Patients should NOT stop using the ventilator unless they are instructed by their clinician," the FDA stated in its alert.
Inside the Component Failure
ResMed identified the problem in a subset of Astral 100 and Astral 150 units. A component called a supercapacitor can leak over time. That leakage can damage circuitry on the printed circuit board assembly, and the damage can push the ventilator into a fail-safe state.
The failure presents differently depending on when it happens. If a device is actively delivering therapy, therapy stops, a maximum volume alarm sounds, and the screen may show a safety system fault. If the device is in standby, the alarm sounds, but the screen may show nothing at all, and therapy simply will not start when someone tries to begin it.
In both situations, the ventilator can no longer deliver breaths. ResMed reported five serious injuries and no deaths connected to the issue as of June 23.
Affected devices carry serial numbers below 22241890149. Spare circuit boards built before October 2024 are also covered. Devices that have already had a non-affected main board installed are not implicated, which is why the company is asking providers to verify the board currently inside each unit rather than relying on the machine's original build date.
Home Ventilator Users Face a Parts Shortage
The supply problem is the part of this alert with the clearest household consequence. ResMed told customers on June 25 that circuit board availability is significantly constrained and that it cannot immediately correct every affected ventilator. The company is running a phased approach, inspecting and mitigating risk during routine service visits and prioritizing patients at highest clinical risk using a three-tier framework provided to clinicians.
That means many families will wait. For a ventilator-dependent patient, waiting is only tolerable if a backup exists. ResMed instructed patients to keep alternate ventilation equipment, such as a backup ventilator or a manual resuscitator, available, checked, and ready. It also reminded caregivers that anyone monitoring a ventilator-dependent patient needs current training and genuine confidence responding to alarms.
The shortage reaches beyond current users. ResMed advised clinicians to prioritize other ventilator options for new patients because Astral availability is expected to be limited. Families starting home ventilation this year may find their durable medical equipment supplier steering them toward a different device, and that is a supply decision rather than a comment on any individual patient's needs.
Cost and access questions follow. Home ventilators are typically covered under Medicare Part B durable medical equipment benefits or comparable commercial policies, and a manufacturer correction should not generate a patient bill. Families who are told otherwise, or who lack a functioning backup device, can raise it with their equipment supplier, their prescribing clinician, or their plan's case manager. Patients enrolled in state Medicaid programs can ask whether a second device qualifies as medically necessary given a documented manufacturer notice.
A Post-Philips Warning System Gets an Early Test
This alert did not arrive through the older recall pathway. It came through the FDA's Early Alert program, a communications approach the agency's device center expanded to all medical devices in September 2025. The premise is that the public should hear about a potentially high-risk device problem while the FDA is still gathering information, rather than months later when a recall is formally classified.
That change grew out of years of criticism over how slowly patients learned about respiratory device defects. The Philips Respironics foam recall that began in 2021 covered millions of sleep and ventilation devices, produced a federal consent decree in 2024, and left many patients unaware for long stretches that their machine was implicated.
The two events should not be read as equivalent. The Philips action involved degrading sound abatement foam across an enormous installed base. The ResMed issue involves an electrical component in a defined set of serial numbers, with five reported serious injuries to date. What they share is a test of the same question: whether the people breathing through these machines find out in time to act.
On timing, the newer system performed differently. ResMed's customer letter went out June 25, and the FDA posted its public alert on July 15, roughly three weeks later, while explicitly noting that the agency was still reviewing the issue. Whether that notice actually reached individual patients rather than only distributors and clinicians is not yet documented, and it is the open question worth watching.
Steps for Patients and Caregivers Right Now
Anyone using an Astral 100 or Astral 150 should confirm with their equipment supplier or clinician whether their specific board is affected, and should not attempt to determine this independently from the outside of the device. Continue therapy as prescribed unless a clinician says otherwise.
Confirm that backup ventilation equipment is present, tested, and reachable, and that everyone in the household who might respond to an alarm knows what the alarm means. Households that do not currently have a backup should raise that gap with the prescribing clinician promptly rather than waiting for the next scheduled visit.
Patients or clinicians who experience a device problem can report it through the FDA's MedWatch program. U.S. customers with questions can reach ResMed through its contact page.
What remains unknown is substantial. The FDA has not classified this as a recall, so the agency's own hazard assessment is still pending. Neither the number of affected devices in U.S. homes nor the expected timeline for full correction has been published. The company has said it continues to evaluate additional corrective pathways, and the FDA has said it will update its alert page as significant new information becomes available. MedicalDaily will monitor both.
Frequently Asked Questions
Which ventilators are covered by this alert? ResMed Astral 100 and Astral 150 ventilators built before October 2024, with serial numbers below 22241890149, plus certain spare circuit boards built before that date.
Should patients stop using an affected ventilator? No. The FDA and ResMed both instruct patients to continue therapy unless a treating clinician directs otherwise, and to keep backup ventilation equipment ready.
What happens if the component fails? The ventilator can enter a fail-safe state in which therapy stops or will not start, accompanied by a maximum volume alarm. The device cannot deliver breaths until alternative ventilation is provided.
How many people have been hurt? ResMed reported five serious injuries and no deaths as of June 23, 2026. That figure could change as more reports are reviewed.
Why are repairs taking so long? Replacement circuit board availability is significantly constrained. ResMed is inspecting devices during routine service and prioritizing patients at highest clinical risk first.
Is this the same as the Philips recall? No. The defect type, the mechanism, and the documented scale differ. The comparison being drawn here is about how quickly patients are notified, not about the size of the two events.
Where can families check for updates? The FDA's Early Alert page for this issue is updated as new information becomes available, and equipment suppliers should be contacting affected patients directly.
