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

FDA device recall Z-2223-2026 · posted 2026-06-03 · Open, Classified

Recall details

Recalling firm

Fresenius Kabi USA, LLC

Reason for recall

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.

Action taken

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.

Root cause

Software design (manufacturing process)

Status

Open, Classified

Product code

FRN

Quantity affected

32 systems

Distribution

US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

Date initiated

2026-05-06

Date posted

2026-06-03

Location

North Andover, MA

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