Ivenix Infusion System (Fresenius) – Pump Anomalies (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
UDI-DI: 00811505030122. Software 5.9.2 and prior
Products Sold
UDI-DI: 00811505030122. Software 5.9.2 and prior
Fresenius Kabi USA, LLC is recalling Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outp due to Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an al. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
Recommended Action
Per FDA guidance
Fresenius Kabi began notifying consignees on 01/10/2024 via emailed letter. Consignees were instructed to check if your device contains the affected software, review and become familiar with the temporary Risk Mitigation actions for each anomaly outlined in the letter and notify customers/personnel if the product was transferred or further distributed. Additionally, to facilitate the installation of the pump software, LVP SW 5.10, your facility must install the new Ivenix Infusion Management System (IMS) software version (5.2) on your IMS server and install the new software version (5.10) for the Ivenix Large Volume Pump (LVP). Please post this letter in areas that affected devices are stored and used such that users of this device are aware of the issues and recommended risk mitigation measures. Lastly, consignees were requested to complete and return the Customer Reply Form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, GA, ID, MI, MS, NE, NV, NJ, OK, TX, UT, VA, WA, WI
Page updated: Jan 10, 2026