Fresenius Kabi issues correction for Ivenix infusion pumps over battery health software bug

The U.S. Food and Drug Administration has classified a correction for Fresenius Kabi’s Ivenix Large Volume infusion pump as the most serious type of recall. The action does not require removal of the devices from use, but a software fix is needed to address a potential safety issue.

A software anomaly in version 5.10.2 can display an inaccurate battery health value, which could lead users to rely on battery power when the pump should remain connected to AC. If the pump runs on a low battery, it may shut down within five minutes, creating a risk of interruption to therapy.

Fresenius Kabi sent a letter on April 30 advising customers to keep the pumps plugged in at all times and to reconnect to AC immediately if a “Battery Extremely Low” alarm sounds. The letter also instructs staff to transition therapy without delay if power cannot be restored before shutdown.

This correction is distinct from earlier notices issued in February and July 2026 that addressed other software and hardware issues with the same pump model.