Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS)

Potential software 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.

LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

Consignees were notified on about 05/06/2026 via letter. Consignees were informed of the issue, risk associated, and instructed to keep the Ivenix pump plugged in at all times rather than rely on battery and if a "Battery Extremely Low" alarm occurs while on battery, immediately connect the pump to AC. 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. Consignees were also instructed to notify other users if applicable, notify customers if affected units were transferred or distributed, and post the provided Safety Tip Sheet, Battery Health Software Anomaly in the Ivenix Large Volume Pump (LVP) notice alongside this letter in all areas where affected pumps are stored and used. consignees were asked to complete and return the provided Customer Reply Form.

• FDA enforcement recordOfficial FDA database entry for Z-2223-2026
• FDA 510(k) clearance · K183311The device's official FDA premarket clearance record
• FDA device classification · FRNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Fresenius Kabi USA, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.