The company is advising users to keep devices plugged into AC power following a software anomaly that may cause false battery readings and unexpected shutdowns.
Fresenius Kabi is voluntarily recalling the software for its Ivenix Large Volume Pump due to an anomaly that can cause the device to report false battery-health values and shut down unexpectedly. The US Food and Drug Administration has identified this as a Class I recall, the most serious type, indicating that continued use without correction could lead to serious injury or death.
The issue affects the Ivenix Large Volume Pump running software version 5.10.2. According to the company, the software error typically displays a battery-health value of 69% before triggering a battery-depletion alarm. If the pump is not reconnected to AC power, it will shut down within five minutes.
Fresenius Kabi recommends that all units remain plugged in at all times instead of relying on battery power until a software update is available, which is expected in July 2026. If a “Battery Extremely Low” alarm occurs while on battery power, users should immediately connect the pump to AC mains power.
If a device shuts down unexpectedly, therapy may be interrupted or delayed. Depending on the patient’s condition and the urgency of the therapy, such interruptions can reduce treatment effectiveness and lead to serious health consequences. Patients at greatest risk include those who are critically ill or receiving short half-life medications.
For patient transport, the company advises facilities to have a plan for AC access and ensure a registered nurse accompanies patients receiving critical or short half-life infusion therapies. Facilities that distribute or transfer devices to other locations should notify all anticipated users of this correction.
As of April 30, Fresenius Kabi has reported no serious injuries or deaths associated with this issue. This correction is separate from previous communications issued in February 2026 and July 2026 regarding other software and hardware issues with the Ivenix system.
The Ivenix Infusion System is used in hospitals and outpatient care environments for the controlled administration of fluids, including pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures. It is indicated for use in adult, pediatric, and neonate patients.
Customers in the US with adverse reactions, quality problems, or questions about this recall should contact Fresenius Kabi Support at [email protected] or (855) 354-6387.
