FDA Lists Fresenius Kabi Ivenix Pump Software Correction as Most Serious Recall

The US Food and Drug Administration has identified Fresenius Kabi's correction of software for its Ivenix large volume infusion pumps as the most serious type of recall. According to the FDA's notice, posted February 25, Ivenix Large Volume Pump software version 5.10.1 and earlier contains two anomalies that can delay or interrupt infusions, and Fresenius Kabi has reported two serious injuries and no deaths associated with the issue as of November 18.

The action corrects devices rather than removing them from use, the FDA said. The company is directing customers to update the pump software to version 5.10.2 as soon as possible. The Oncology Nursing Society reported the FDA announcement on February 25.

Two software anomalies

According to the notice, Ivenix pumps running on battery power for extended periods may inaccurately report remaining battery capacity, which can result in an unexpected shutdown without the standard low-battery alarm sequence at 30, 15, 5 and 1 minutes remaining. The FDA said pumps with greater accumulated battery use are more susceptible.

In the second anomaly, if a clinician enters a rate with two leading zeros, such as 0010, that exceeds drug library limits, pressing "Back" or "OK" on the Set Rate screen sends the pump into a fail-stop alarm state that freezes its interface, the notice says. That can delay or interrupt therapy if reprogramming stops an active infusion.

"Fresenius Kabi stated that the affected software contains anomalies that could cause serious patient harm or death," the FDA said. The agency added that the extent of harm from a delayed or interrupted infusion depends on how long it takes to identify and resolve the issue, the patient's underlying condition and how critical the therapy is.

Software update and battery checks

Fresenius Kabi sent customers a letter on November 14 with temporary measures to follow until the update is installed, the FDA said. They include keeping pumps plugged in during use whenever possible and avoiding programming infusion rates with two leading zeros. To install the fix, facilities first update the Ivenix Infusion Management System server software to version 5.2.2, after which the pumps check for version 5.10.2, according to the notice.

After both updates, the company asked customers to review the battery health of their pump fleets and to replace both batteries in any pump showing battery health of 70% or less. The notice says a battery health level of 70% or below "can adversely affect performance." Pumps cannot be used while the software update is running.

The FDA's recall database entry, recall number Z-0885-2026, shows the firm began the recall on November 14, 2025, and the entry was posted on December 16, 2025. It lists Fresenius Kabi USA of North Andover, Massachusetts, as the recalling firm, the product as Ivenix Infusion System large volume pump software LVP-SW-0005 under 510(k) number K183311, and US distribution in 20 states.

According to the FDA, the Ivenix Infusion System is indicated for use in hospitals and outpatient care to deliver fluids by intravenous, intra-arterial, epidural and subcutaneous routes to adult, pediatric and neonatal patients. The fluids can include drugs, red blood cells, platelets and plasma.