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Infusion Pump Corrections for Ivenix Large Volume Infusion Pumps

The FDA is aware that Fresenius Kabi has sent letters to affected customers regarding two different issues that could delay or interrupt treatment and recommended all infusion pumps be corrected prior to continued use.

• Software Issue: Fresenius Kabi is voluntarily recalling Large Volume Pump Software, version 5.10.2 (Product Code LVP-SW-0005) embedded in the LVP-0004. This software introduced an anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power, presenting a remote but serious risk of patient harm. Until a software update becomes available (expected July 2026), the Ivenix pump should remain plugged in at all times. As of April 30, Fresenius Kabi has reported no serious injuries and no deaths associated with this issue.

• Ivenix Large Volume Pumps that have been Dropped or Severely Jarred: Fresenius Kabi stated that the pump touchscreen may display unintended behaviors, including random screen touches and lack of screen responsiveness to user input. In most cases, this behavior is the result of a loosened touchscreen input cable. Unintended touchscreen behavior on the pump, such as random screen touches or lack of responsiveness, can affect the user's ability to manage therapy. As of May 6, Fresenius Kabi has reported two serious injuries and no deaths associated with this issue.

These recalls involve correcting devices and does not involve removing them from where they are used or sold. The FDA has identified these recalls as the most serious type. These devices may cause serious injury or death if you continue to use them without correction.

Questions?

Customers in the U.S. with adverse reactions, quality problems, or questions about either recall should contact Fresenius Kabi Support at Ivenix_support@fresenius-kabi.com or (855) 354-6387.