Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump

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

Affected ProductThe FDA is aware that Fresenius Kabi has issued a letter to affected customers recommending all infusion pumps be corrected prior to continued use. This issue affects the same devices and is separate from those described in the February 2026 communication, “Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software,” and the July 2026 communication, “Infusion Pump Correction: Fresenius Kabi Issues Correction for Dropped or Jarred Ivenix Large Volume Infusion Pumps.”Affected devices:Ivenix Large Volume Pump (LVP-0004)Software Version 5.10.2 (LVP-SW-0005)UDI: 00811505030320What to DoUnits should be plugged in at all times instead of relying on battery power. On April 30, Fresenius Kabi sent all affected customers a letter recommending the following actions:Keep the Ivenix pump plugged in at all times rather than relying on the battery, until a software update becomes available.If a "Battery Extremely Low" alarm occurs while on battery, immediately connect the pump to AC.

This alarm will shut down the pump within five minutes unless it is reconnected to AC mains power. If AC cannot be established before shutdown, transition therapy without delay using an alternate device, per clinical judgment and facility policy.Transport Planning: For any transport of a patient on an affected pump, have a plan for AC access. For patients receiving critical or short half-life infusion therapies, ensure an RN accompanies the patient during transport.Notify other users if applicable.

If your facility distributes or transfers devices to other locations, notify all anticipated users of this correction.Post the provided Safety Tip Sheet “Battery Health Software Anomaly in the Ivenix Large Volume Pump (LVP)” and the Urgent Medical Device Correction notice in all areas where affected pumps are stored and used.Reason for CorrectionFresenius 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.If the device unexpectedly shuts down due to the Battery Extremely Low alarm, therapy may be interrupted or delayed. Depending on the patient's condition and the urgency of the therapy, such interruptions can reduce treatment effectiveness and may lead to serious health consequences.

Patients at greatest risk include critically ill patients and patients receiving short half-life medications.As of April 30, Fresenius Kabi has reported no serious injuries and no deaths associated with this issue.Device UseThe Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intravenous, intra-arterial, epidural, and subcutaneous, to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy.Contact InformationCustomers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Fresenius Kabi Support at Ivenix_support@fresenius-kabi.com or (855) 354-6387.Additional FDA ResourcesFDA’s Enforcement ReportMedical Device Recall DatabaseUnique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use.

The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.