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# Fresenius Recalls Ivenix Infusion Pump Software
- URL: https://www.fdaweb.com/fresenius-recalls-ivenix-infusion-pump-software/
- Published: 2024-10-01T12:00:00.000Z
- Updated: 2026-09-14T14:42:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157891

Fresenius Kabi is recalling (Class 1 device correction) its Ivenix Infusion System Large Volume Pump software due to multiple software anomalies and a cybersecurity vulnerability that have the potential to result in a therapy delay or under dosage. The use of affected product may cause serious adverse health consequences, including temporary irregular heartbeat (arrhythmia), hyperglycemia, low or high blood pressure (hypotension or hypertension), a lack of sedation (undersedation), blood clotting changes and death,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-software-correction-fresenius-kabi-usa-llc-issues-correction-ivenix-infusion-system?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. To date, there have been no reported injuries or deaths.

The device is used in hospitals/outpatient care facilities for the controlled administration of fluids to patients through accepted methods such as intravenous line, arterial lines, epidurals, and subcutaneous delivery.