Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 98945

What happened

Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.

Who may be affected

• People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
• A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What to do

Affected products and models

Distribution

Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;

Units affected

See official FDA record

Category

Infusion pumps

Timeline

1. May 6, 2026

   Recall initiated

   Date recorded by the FDA.

2. May 29, 2026

   Posted by FDA

   The recall event appeared in the FDA source.

3. Oct 8, 2026

   Last checked

   MedWatcher last reconciled this record with the openFDA export.