Fresenius Kabi USA, LLC has issued a recall for the LVP Software of the Ivenix Infusion System, specifically version 5.8.0, due to multiple software anomalies that could potentially result in serious harm or death to patients.

This recall, classified by the FDA as a Class I — the most serious category — entails updating the software rather than removing the product from use.

The recall impacts a relatively small number of devices, with only 17 units affected across the United States. The distribution of these units occurred from March 6, 2023, to March 20, 2024, and the firm initiated the recall on March 7, 2024.

The Ivenix Infusion System is utilized in various medical settings, including hospitals and outpatient care, to administer fluids through several methods such as intravenous, arterial, epidural, and subcutaneous delivery. These fluids range from medications and blood products to other necessary agents for both adult and pediatric patients, including neonates and infants.

In response to the identified software issues, Fresenius Kabi is rolling out a new software version, 5.9.1, to replace the problematic version. This upgrade aims to correct the anomalies without necessitating the physical removal of the devices from healthcare facilities.

As of now, there have been no reported injuries or deaths associated with the issue.

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