FDA Medical Device Recall

Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death

Please be aware, this recall is a correction, not a product removal.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

KCER Release Date: April 17, 2024

To: KCER Distribution list- including ESRD Network EDs and QIDs

• Product Names: LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

• Product Codes: FRN

• Distribution Dates: March 6, 2023 to March 20, 2024

• Devices Recalled in the U.S.: 17

• Date Initiated by Firm: March 7, 2024

Device Use

The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids to patients through accepted methods such as intravenous line (IVs), arterial lines, epidurals, and subcutaneous (under the skin) delivery. These fluids include medications, blood products such as red cells or plasma, or other agents needed for treatment of adult and pediatric patients, including neonates and infants.

Reason for Recall

Fresenius Kabi USA, LLC. is recalling their Ivenix Infusion System (IIS), LVP Software, an infusion pump software. The recall will take the form of a software update. The reason for the recall is that multiple software anomalies were occurring that have the potential to result in serious patient harm or death.

To remedy this issue, Fresenius Kabi is releasing a new software version (5.9.1) for the Ivenix Large Volume Pump (LVP).

There have been no reports of injuries or deaths associated with this issue.

Who May be Affected

• People who are treated in a health-care setting using the Ivenix Infusion System.

• Health care personnel who use Ivenix Infusion Systems to deliver blood and medications to patients in health care settings.

What to Do

On March 7, 2024, Fresenius Kabi sent all affected customers an Urgent Medical Device Field Correction.

The letter requested customers to:

• Update all LVPs to software version 5.9.1 by reaching out to a Fresenius Kabi representative (1-978-775-8100) to have it installed.

• Complete the Customer Reply Form included with this letter to acknowledge receipt.

Contact Information

Customers in the U.S. with questions about this recall should contact Fresenius Kabi at 1-978-775-8100.

Additional Resources: 

• Class 1 Device Recall Ivenix Infusion Pump LVP Software (fda.gov)

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 using an online form, regular mail, or FAX.