UK regulator issues safety alert for some ResMed Astral ventilators after risk of sudden stoppage

The UK medicines regulator has issued a national patient-safety alert over some widely used ResMed Astral ventilators, warning that the devices can unexpectedly stop delivering life-sustaining breathing support and create an immediate risk for patients who depend on them.

The Medicines and Healthcare products Regulatory Agency, or MHRA, said in a National Patient Safety Alert issued Monday that the problem affects ResMed Astral 100 and Astral 150 ventilators, along with associated printed circuit board assembly spare parts, manufactured before October 2024. The practical message for patients and carers is not to stop treatment on their own: “NOTE : Patients should not stop using their ventilator unless they are advised to do so by their clinical team and an alternative means of ventilation is available.”

Instead, hospitals, home-ventilation services and carers are being told to identify affected devices, make sure backup ventilation is immediately available for ventilator-dependent patients, and prioritise the people at highest risk. Providers should check serial numbers and manufacturing dates against ResMed’s affected-device lists. The MHRA alert, numbered NatPSA/2026/004/MHRA, sets a deadline of Feb. 17, 2027, for required actions.

ResMed had already warned customers about the same issue in an Urgent Field Safety Notice dated June 25 under the heading: “URGENT MEDICAL DEVICE CORRECTION Astral 100/150 – Ventilator may stop delivering therapy due to internal component issue.”

The fault is linked to an internal supercapacitor, a component used to store and release electrical energy. According to ResMed and regulators, that part may leak electrolyte over time. The leaked material can damage circuitry on the ventilator’s printed circuit board assembly and push the machine into a fail-safe state — meaning it stops delivering ventilation.

If that happens while therapy is being delivered, ventilation stops immediately, a high-priority audible alarm sounds at maximum volume, and the screen may show a red “Safety System Fault” message. If the problem occurs while the device is in standby, the alarm still sounds, but therapy will not start. In either case, the device becomes inoperable and alternative ventilation is required immediately.

That risk matters because Astral ventilators are portable machines used in homes, hospitals and during transport for people who need continuous or intermittent breathing support. The alert therefore extends beyond hospital wards to patients in the community who may rely on the devices every day.

The MHRA said healthcare providers should plan around global shortages of replacement printed circuit board assemblies, making it especially important to identify affected units quickly and prioritise inspections or corrections for the most vulnerable patients. The affected population includes ventilators with serial numbers below 22241890149, but for most readers the key step is for providers to use ResMed’s lists rather than guess.

ResMed said the problem is infrequent, estimating a rate of about 0.1% over a device’s service life. Even so, regulators are treating it as a high-severity safety issue because of the consequences if a failure occurs during active ventilation. In the United States, the Food and Drug Administration posted a public notice in July and later classified the action as a Class I recall or correction, its most serious recall category. The FDA’s advice was similarly direct: “DO NOT stop using these ventilators.”

ResMed said in its field notice that it had received five adverse-event reports, one of them serious, and that all patients recovered following intervention. A later FDA public notice said ResMed had reported five serious injuries and no deaths. The manufacturer’s public account and the FDA’s public account do not match on the seriousness count, and no public explanation for that discrepancy was included in the notices.