The U.S. Food and Drug Administration (FDA) has issued an alert regarding two critical issues with Fresenius Kabi's Ivenix Large Volume Infusion Pumps, prompting the company to initiate corrections for devices that could delay or interrupt patient treatment.
One issue involves software version 5.10.2, which can cause a false battery-health reading and trigger a shutdown unless the pump is connected to AC power. Fresenius Kabi is recalling this software, with an update anticipated by July 2026. Until then, pumps should remain plugged in. No serious injuries or deaths have been reported for this issue as of April 30.
The second concern affects Ivenix pumps that have been dropped or severely jarred, potentially leading to unresponsive or randomly touching touchscreens due to a loosened input cable. This can impair a user's ability to manage therapy. Two serious injuries have been reported as of May 6 related to this problem.
The FDA has classified these as the most serious type of recall, indicating that continued use without correction could lead to serious injury or death. These actions involve correcting devices, not removing them from use.