Fresenius Kabi has issued a correction for certain Ivenix Large Volume Pump (LVP) software versions following a Class I recall designation by the US Food and Drug Administration (FDA).
Class I recalls are the agency's most serious risk category.
The recall relates to Ivenix LVP software version 5.10.1 and earlier (Product Code: LVP-SW-0005).
Rather than removing devices from the market, the action requires healthcare providers to update affected systems to software version 5.10.2 to mitigate potentially serious risks.
According to the FDA, the software anomalies could result in delays or interruptions to infusion therapy, with the potential to cause serious injury or death if not corrected.
As of 18 November 2025, two serious injuries and no deaths have been reported in connection with the issue.
The Ivenix Infusion System is used in hospital and outpatient settings for the controlled administration of fluids and medications via intravenous, intra-arterial, epidural and subcutaneous routes, including the delivery of pharmaceutical drugs, blood products and other therapies to adult, paediatric and neonatal patients.
Two primary software anomalies have been identified.
The first affects pumps operating on battery power for extended periods. In some cases, the device may inaccurately report remaining battery capacity, potentially leading to unexpected shutdowns without triggering the standard low-battery alarm sequence.
The regulator noted that pumps with greater accumulated battery usage may be more susceptible.
The second issue occurs when a clinician enters a rate with two leading zeros (for example, 0010) that exceeds drug library limits.
Pressing "Back" or "OK" on the set rate screen can cause the pump to enter a fail-stop alarm state, freezing the interface. This may delay or interrupt therapy, particularly if reprogramming halts an active infusion.
In a letter sent to customers on 14 November 2025, Fresenius Kabi instructed users to update both the Ivenix Infusion Management System (IMS) software to version 5.2.2 and the LVP software to version 5.10.2.
Until updates are completed, healthcare providers are advised to keep pumps plugged in whenever possible and avoid programming infusion rates with two leading zeros.
Facilities are also instructed to review battery health across their pump fleet following the software update and replace batteries with health below 70%.
The Ivenix platform has faced prior regulatory scrutiny, including earlier recalls and a 2024 warning letter regarding quality system processes.
Fresenius Kabi acquired Ivenix in 2022 as part of a strategic expansion of its infusion therapy portfolio.
The latest Class I recall underscores the ongoing regulatory focus on software reliability and post-market surveillance in connected infusion systems, an area of increasing importance for manufacturers operating in highly regulated healthcare environments.