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Ivenix Infusion System (IIS)

by Ivenix, Inc.

510(k) K183311

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

21 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183311 Date7 Jun 2019ClearedStatusActive

Recalls

25 recalls · 21 ongoing · FDA

    • Ongoing Z-2224-2026 FDA Class I initiated 6 May 2026

    Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.

    • Ongoing Z-2223-2026 FDA Class I initiated 6 May 2026

    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.

    • Ongoing Z-2274-2026 FDA Class II initiated 4 Feb 2026

    Potential for the Cassette Loading Lever to break.

    • Ongoing Z-1048-2026 FDA Class II initiated 21 Nov 2025

    Emphasizing instructions for LVP duration programming located in the IFU.

    • Ongoing Z-0885-2026 FDA Class I initiated 14 Nov 2025

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

    • Ongoing Z-0586-2026 FDA Class I initiated 3 Nov 2025

    Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

    • Ongoing Z-0848-2026 FDA Class II initiated 3 Nov 2025

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

    • Ongoing Z-0378-2026 FDA Class II initiated 3 Sep 2025

    Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

  • 4 recalls, same reason

    • Ongoing Z-2233-2025 FDA Class II initiated 24 Jun 2025
    • Ongoing Z-2232-2025 FDA Class II initiated 24 Jun 2025
    • Ongoing Z-2235-2025 FDA Class II initiated 24 Jun 2025
    • Ongoing Z-2234-2025 FDA Class II initiated 24 Jun 2025

    Potential for external cassette leaks

    • Ongoing Z-1869-2025 FDA Class I initiated 12 May 2025 on shared 510(k) K183311

    Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.

    • Ongoing Z-1019-2025 FDA Class I initiated 10 Jan 2025

    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.

    • Ongoing Z-0763-2025 FDA Class I initiated 6 Dec 2024

    Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

    • Ongoing Z-3153-2024 FDA Class I initiated 30 Aug 2024

    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.

    • Ongoing Z-2721-2024 FDA Class I initiated 1 Aug 2024 on shared 510(k) K183311

    A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

    • Ongoing Z-1484-2024 FDA Class I initiated 7 Mar 2024

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

    • Ongoing Z-0549-2024 FDA Class I initiated 29 Nov 2023

    The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.

    • Ongoing Z-1313-2023 FDA Class I initiated 10 Mar 2023

    Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.

    • Ongoing Z-2635-2023 FDA Class II initiated 22 Apr 2022

    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

    • Completed Z-1283-2024 FDA Class II initiated 10 May 2023

    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.

    • Completed Z-1282-2024 FDA Class II initiated 16 Sep 2022

    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.

    • Terminated Z-0002-2023 FDA Class I initiated 8 Sep 2022 on shared 510(k) K183311

    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.

    • Terminated Z-1381-2022 FDA Class II initiated 22 Apr 2022 on shared 510(k) K183311

    Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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