This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
The FDA is aware that Fresenius Kabi has issued a letter to affected customers recommending all infusion pumps be corrected prior to continued use. This issue affects the same devices and is a separate from those described in the February 2026 communication, “Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software” and the July 2026 communication, “Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump.”
What to Do
Do not use a device that has been dropped or severely jarred. Devices that have been dropped or severely jarred should be removed from use immediately, even if no damage is visible.
On April 30, Fresenius Kabi sent all affected customers a letter recommending the following actions:
- If a unit has been dropped or severely jarred, remove it from service, even if no damage is visible.
- Once the pump has been removed from service, or if you have questions about whether to do so after a drop, contact Fresenius Kabi customer support at Ivenix_support@fresenius-kabi.com or (855) 354-6387.
- Follow the actions outlined in the “Proper Handling of the Ivenix Large Volume Pump (LVP)” Safety Tip Sheet, included in Fresenius Kabi’s Urgent Medical Device Correction notice. This tip sheet provides temporary instructions until Fresenius Kabi updates the IFU to clarify that devices dropped or severely jarred must be taken out of service.
Reason for Correction
Fresenius Kabi stated that the pump touchscreen may display unintended behaviors, including random screen touches and lack of screen responsiveness to user input. In most cases, this behavior is the result of a loosened touchscreen input cable.
Testing confirmed that the cable became loose when these units were dropped on a hard surface or experienced severe jarring. These events did not necessarily cause visible damage but were of sufficient force to loosen the cable.
Unintended touchscreen behavior on the pump, such as random screen touches or lack of responsiveness, can affect the user's ability to manage therapy. This could lead to an interruption or delay of therapy. Such occurrences may lead to adverse health consequences, including the risk of serious injury or death.
As of May 6, Fresenius Kabi has reported two serious injuries and no deaths associated with this issue.
Device Use
The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intravenous, intra-arterial, epidural, and subcutaneous, to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Fresenius Kabi Support at Ivenix_support@fresenius-kabi.com or (855) 354-6387.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.