Class I recallOngoing

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 recall — FDA event 98009

FDA · FDA event 98009 · Posted Dec 16, 2025

Published Dec 16, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

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 the official notice recommends

Consignees were emailed an "URGENT - Medical Device Field Correction" notice dated 11/14/25. The notice instructs consignees to review and become familiar with the provided notification's risk mitigation actions; the notice is to be forwarded if affected units were further distributed and users are to be notified. Consignees are to facilitate the installation of the new Ivenix Infusion Management System (version 5.2.2) and Large Volume Pump (5.10.2) software versions utilizing the provided instructions. Consignees are to note that the LVP will not be available for use during the update. Completed Customer Reply Forms may be sent via email to fkmd.fieldactions@fresenius-kabi.com.
Customer questions can be directed to Customer Support via email at Ivenix_support@fresenius-kabi.com or by phone at 1-855-354-6387.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 by Fresenius Kabi USA, LLC.

Products affected by FDA event 98009
Model	Description	Lot / serial range	Manufactured	Status
Z-0885-2026	Z-0885-2026	Software Versions 5.10.1 and prior; UDI: 00811505030122.	Not provided in the normalized record	Ongoing

Distribution: US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Nov 14, 2025
Recall initiated
Date recorded by the FDA.
Dec 16, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 98009
Published: Dec 16, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 recall — FDA event 98009

FDA · FDA event 98009 · Posted Dec 16, 2025

Published Dec 16, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 by Fresenius Kabi USA, LLC.

Products affected by FDA event 98009
Model	Description	Lot / serial range	Manufactured	Status
Z-0885-2026	Z-0885-2026	Software Versions 5.10.1 and prior; UDI: 00811505030122.	Not provided in the normalized record	Ongoing

Distribution

US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.

Units affected

See official FDA record

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

FDA · FDA event 98872Posted Jun 5, 2026

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 recall — FDA event 98009

Follow Ivenix Infusion System (IIS), LVP Software LVP-SW-0005

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 recall — FDA event 98009

Follow Ivenix Infusion System (IIS), LVP Software LVP-SW-0005

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline