Agency classClass IOur severity:Severe FDA (Devices)·Z-1019-2025·Announced 2025-02-12

Ivenix Infusion System software recalled for pump malfunction risk

The FDA recalled Ivenix Infusion System software versions 5.9.2 and earlier for potential device malfunctions that could affect medication delivery. Two known anomalies may cause pump failure or improper infusion rates.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I, which per FDA regulations indicates potential for serious patient harm. The identified software defects could result in device malfunction or improper medication delivery. Although no patient injuries have been reported, the Class I classification and critical nature of infusion systems in healthcare necessitate this severity level.

Plain-English summary

The Ivenix Infusion System (IIS) Large Volume Pump (LVP) software, versions 5.9.2 and earlier, is being recalled by the FDA. The system is used in hospitals and outpatient care settings to deliver fluids and medications. A total of 23 systems have been distributed across multiple US states including California, Colorado, Georgia, Idaho, Michigan, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Texas, Utah, Virginia, Washington, and Wisconsin.

Two software anomalies have been identified. First, if the Pause Audio alarm option is repeated 70 or more times during an alarm condition, the pump may become nonfunctional. Second, if a secondary infusion is started at the exact moment a primary infusion completes and the VTBI (volume to be infused) reaches zero, the system will incorrectly switch to the primary infusion and continue delivering at the previously programmed primary rate until the infusion is manually stopped or the bag is empty.

Healthcare facilities using this system should contact the manufacturer, Fresenius Kabi USA, LLC, to obtain updated software versions that address these issues. Patients and providers should be aware of these potential device malfunctions when managing infusion therapy.

The recalled product

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.
Manufacturer: Fresenius Kabi USA, LLC
Category: Medical Device — Infusion Pump
Hazard: pump-malfunction
software-defect
infusion-error
Affected units: 23

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI-DI: 00811505030122. Software 5.9.2 and prior

Distribution

Distributed in 15 states:

Same manufacturer · Fresenius Kabi USA, LLC

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