Ivenix, Inc. 2.0Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

10 FDA recall records name this device's identifier, 7 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 6, 2026Open, Classified

   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.

   Z-2223-2026 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

2. Nov 21, 2025Open, Classified

   Emphasizing instructions for LVP duration programming located in the IFU.

   Z-1048-2026 · Root cause: Use error · Recall details · FDA record ↗

3. Nov 14, 2025Open, Classified

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

   Z-0885-2026 · Root cause: Software design · Recall details · FDA record ↗

4. Jan 10, 2025Open, Classified

   Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

   Z-1019-2025 · Root cause: Software Design Change · Recall details · FDA record ↗

5. Aug 30, 2024Open, Classified

   The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.

   Z-3153-2024 · Root cause: Software design · Recall details · FDA record ↗

6. Mar 7, 2024Open, Classified

   Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.

   Z-1484-2024 · Root cause: Software Design Change · Recall details · FDA record ↗

7. May 10, 2023Completed

   Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.

   Z-1283-2024 · Root cause: Software design · Recall details · FDA record ↗

8. Sep 16, 2022Completed

   Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.

   Z-1282-2024 · Root cause: Software design · Recall details · FDA record ↗

9. Sep 8, 2022Terminated

   The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.

   Z-0002-2023 · Root cause: Software design · Recall details · FDA record ↗

10. Apr 22, 2022Open, Classified

    Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set

    Z-2635-2023 · Root cause: Device Design · Recall details · FDA record ↗