The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.
Baxter is permanently removing the Life2000 Ventilation System due to a cybersecurity issue discovered through internal testing, according to a recall alert from the US Food and Drug Administration (FDA).Â
If an unauthorized person were to gain physical access to an unattended device, they could potentially change device therapy settings or access device data, according to the alert, which notes that this may lead to the life-supporting air delivery function not working as intended.
Use of the affected product may cause serious adverse health consequences, including injuries caused by device malfunction or complete failure of vital breathing support and death. As of April 10, 2025, Baxter has reported no serious injuries or deaths associated with this issue.
The Life2000 Ventilation System is intended to provide continuous or intermittent breathing support for people who require mechanical ventilation assistance. The system includes both the Life2000 Ventilator and the Life2000 Compressor.Â
It is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the system is used for adult patients who require positive pressure ventilation delivered through an endotracheal tube or a mask. The Life2000 Ventilation System is suitable for use in home and institutional settings and is not intended for ambulance or air transportation.
Baxter sent affected customers an Urgent Medical Device Recall letter recommending they stop using Life2000 ventilators and reach out to their healthcare provider to discuss replacement options.
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