Class I recallOngoing

LVP software of the Ivenix Infusion System (IIS) recall — FDA event 98929

FDA · FDA event 98929 · Posted Jun 3, 2026

Published Jun 3, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Potential software anomaly that 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.

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 notified on about 05/06/2026 via letter. Consignees were informed of the issue, risk associated, and instructed to keep the Ivenix pump plugged in at all times rather than rely on battery and if a "Battery Extremely Low" alarm occurs while on battery, immediately connect the pump to AC. For any transport of a patient on an affected pump, have a plan for AC access. For patients receiving critical or short half-life infusion therapies, ensure an RN accompanies the patient during transport.
Consignees were also instructed to notify other users if applicable, notify customers if affected units were transferred or distributed, and post the provided Safety Tip Sheet, Battery Health Software Anomaly in the Ivenix Large Volume Pump (LVP) notice alongside this letter in all areas where affected pumps are stored and used. consignees were asked to complete and return the provided Customer Reply Form.

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

Affected products and models

This FDA record lists LVP software of the Ivenix Infusion System (IIS) by Fresenius Kabi USA, LLC.

Products affected by FDA event 98929
Model	Description	Lot / serial range	Manufactured	Status
Z-2223-2026	Z-2223-2026	Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

May 6, 2026
Recall initiated
Date recorded by the FDA.
Jun 3, 2026
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: 98929
Published: Jun 3, 2026
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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LVP software of the Ivenix Infusion System (IIS) recall — FDA event 98929

FDA · FDA event 98929 · Posted Jun 3, 2026

Published Jun 3, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists LVP software of the Ivenix Infusion System (IIS) by Fresenius Kabi USA, LLC.

Products affected by FDA event 98929
Model	Description	Lot / serial range	Manufactured	Status
Z-2223-2026	Z-2223-2026	Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2	Not provided in the normalized record	Ongoing

Distribution

US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, 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

LVP software of the Ivenix Infusion System (IIS) recall — FDA event 98929

Follow LVP software of the Ivenix Infusion System (IIS)

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

LVP software of the Ivenix Infusion System (IIS) recall — FDA event 98929

Follow LVP software of the Ivenix Infusion System (IIS)

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