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# Fresenius Recalls Infusion Pump Software
- URL: https://www.fdaweb.com/fresenius-recalls-infusion-pump-software/
- Published: 2024-04-12T12:00:00.000Z
- Updated: 2026-09-14T14:28:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156771

Fresenius Kabi USA has recalled (Class 1) its large-volume pump software of the Ivenix Infusion System due to software anomalies that have the potential to cause underdose, overdose, or a delay in therapy, which could lead to serious patient harm or death, according to an agency [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=206605&ref=fdaweb.com).

The company last month sent a medical device field correction letter to consignees that detailed eleven software anomalies that could pose a potential risk of serious patient harm or death. It included mitigations consignees should perform until the software is updated.

FDA’s notice indicates the problem was traced back to an inadequate software design change.