Fresenius Kabi Ivenix Infusion System LVP Software
The LVP software of the Ivenix Infusion System can report a false battery-health value and trigger a battery-depletion alarm.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
Fresenius Kabi USA, LLC, of North Andover, Massachusetts, recalled the LVP software of the Ivenix Infusion System (IIS), Product Code LVP-SW-0005, after the FDA identified a potential software anomaly. The anomaly can cause the pump to report a false battery-health value, typically 69%, and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power. The recall involved 32 systems and began on May 6, 2026.
The recall was added to the FDA's Enforcement Report on June 3, 2026, and classified the same day. The software was distributed nationwide across 21 states, including California, Florida, Texas, and Washington. For people who have these systems, the FDA's report indicates the anomaly can cause the pump to shut down.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- UDI-DI
- 00811505030122
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Colorado, Florida, Georgia, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington, Wisconsin.
- Event ID
- 98929
- Recall No.
- Z-2223-2026
- Company
- Fresenius Kabi USA, LLCNorth Andover, Massachusetts
- Hazard
- Software defect
- Quantity recalled
- 32 systems
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
