Class II recallOngoing

Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 97939

FDA · FDA event 97939 · Posted Dec 1, 2025

Published Dec 1, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

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

Fresenius Kabi notified consignees on about 11/03/2025 via emailed letter. Consignees were informed of the issue and instructed to account for additional backpressure if check valve is used when configuring the downstream occlusion pressure alarm setting, adjust the occlusion alarm pressure to allow for a more balanced approach between occlusion detection and avoidance of unnecessary alarms, and continue to follow all Instructions for Use and institutional policies regarding infusion pump setup, monitoring, and alarm response. Consignees were requested to ensure all relevant persons within the organization are informed about this letter and the actions as described per the enclosed Tip Sheet on How to Use a Check Valve with the Ivenix Pump & Administration Sets. Additionally, consignees were requested complete and return the Customer Reply Form.
Fresenius Kabi plans to update the Instructions for Use to include the information presented in the "Required Actions for Users", "Important Note on Check Valve Usage" and/or Tip Sheet on "How to Use a Check Valve with the Ivenix Pump & Administration Sets" for which scheduling is still being finalized.

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), Large Volume Pump by Fresenius Kabi USA, LLC.

Products affected by FDA event 97939
Model	Description	Lot / serial range	Manufactured	Status
Z-0848-2026	Z-0848-2026	Model Number: LVP-0004. UDI-DI: 00811505030320.	Not provided in the normalized record	Ongoing

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

Timeline

Nov 3, 2025
Recall initiated
Date recorded by the FDA.
Dec 1, 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: 97939
Published: Dec 1, 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), Large Volume Pump recall — FDA event 97939

FDA · FDA event 97939 · Posted Dec 1, 2025

Published Dec 1, 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), Large Volume Pump by Fresenius Kabi USA, LLC.

Products affected by FDA event 97939
Model	Description	Lot / serial range	Manufactured	Status
Z-0848-2026	Z-0848-2026	Model Number: LVP-0004. UDI-DI: 00811505030320.	Not provided in the normalized record	Ongoing

Distribution

US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, 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

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

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Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 97939

Follow Ivenix Infusion System (IIS), Large Volume Pump

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 97939

Follow Ivenix Infusion System (IIS), Large Volume Pump

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