Ivenix SET-0040-1

• • Ongoing Z-2224-2026 FDA Class I ·initiated 6 May 2026 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  Potential for the Cassette Loading Lever to break.

• • Ongoing Z-1048-2026 FDA Class II ·initiated 21 Nov 2025 ·on shared 510(k) K183311

  Emphasizing instructions for LVP duration programming located in the IFU.

• • Ongoing Z-0885-2026 FDA Class I ·initiated 14 Nov 2025 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311
  • Ongoing Z-2232-2025 FDA Class II ·initiated 24 Jun 2025 ·on shared 510(k) K183311
  • Ongoing Z-2235-2025 FDA Class II ·initiated 24 Jun 2025 ·on shared 510(k) K183311
  • Ongoing Z-2234-2025 FDA Class II ·initiated 24 Jun 2025 ·on shared 510(k) K183311

  Potential for external cassette leaks

• • Ongoing Z-1869-2025 FDA Class I ·initiated 12 May 2025

  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 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  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

  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 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  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 ·on shared 510(k) K183311

  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.

Trade Name

Ivenix

Generic Name

Electric infusion pump administration set, single-use

Model / Ref / Catalog

SET-0040-1

Primary DI / UDI-DI

00811505030573

510(k) Number

K183311 ↗

FDA Product Code

FPA

GMDN Term

Electric infusion pump administration set, single-use

Device Class

Class II

Regulation Number

880.5440

GUDID distribution status

In Commercial Distribution

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