Ivenix Infusion System LVP-0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,328 adverse event reports that list this exact device (DI 00811505030320), received between May 13, 2024 and Sep 30, 2026 — classified as 2 deaths, 15 injuries, 4,311 malfunctions.

The most frequently reported specific device problem is “Program or Algorithm Execution Problem” (1,867 reports).

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

18 other recalls cover devices cleared under the same FDA submission (K183311); they may or may not involve this specific model.

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 18, 2026.

Recalls naming this device

1. May 6, 2026Class IOpen, Classified

   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.

   Z-2224-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Feb 4, 2026Class IIOpen, Classified

   Potential for the Cassette Loading Lever to break.

   Z-2274-2026 · Root cause: Device Design · Recall details · FDA record ↗

3. Nov 3, 2025Class IIOpen, Classified

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

   Z-0848-2026 · Root cause: Labeling design · Recall details · FDA record ↗

4. Sep 3, 2025Class IIOpen, Classified

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

   Z-0378-2026 · Root cause: Process change control · Recall details · FDA record ↗

5. Dec 6, 2024Class IOpen, Classified

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

   Z-0763-2025 · Root cause: Process control · Recall details · FDA record ↗

6. Nov 29, 2023Class IOpen, Classified

   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.

   Z-0549-2024 · Root cause: Process change control · Recall details · FDA record ↗

7. Mar 10, 2023Class IOpen, Classified

   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.

   Z-1313-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,328 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Apparent Adverse Event

  The following has been reported:Biomed reported: Continuous beeping and flashing a red light. Screen was showing an error message, but it was not recorded. Touch screen was unresponsive. Unit was forced to shut down by holding down the power button for 1 minute. Turned on after and behaved normally, however still sending to vendor to investigate previous unusual behavior.A preliminary review identified the following issue: Processor Hardware Failure (Linux Core)An active infusion was stopped. Reporting as a conservative measure. No adverse effects were reported.Additional information is needed to complete the investigation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947863 ↗
• MalfunctionSep 30, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947862 ↗
• MalfunctionSep 30, 2026No Apparent Adverse Event

  The following has been reported:The unit was returned during service after initial complaint investigation was completed for lever arm issues. Secondary Findings: Secondary Findings: Outlet FVA pin stuck in due to excess debris. FVA pin lip seals will be replaced during repair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942192 ↗
• MalfunctionSep 30, 2026No Apparent Adverse Event

  The following has been reported:The unit was returned during service after initial complaint investigation was completed for rear housing issues. Secondary Findings: Unit experienced tubing set misloaded warnings due to sticky FVA pins. Pins and channels were cleaned and unit then passed a mock infusion.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942191 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915528 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915525 ↗
• MalfunctionSep 28, 2026Mechanical Problem; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915523 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  The following has been reported:Problem says service needed.No patient harm.A preliminary review of the logs identified the following issue:Mechanical Hardware Failure (AV Sticky Valve).An active infusion was stopped. Reporting as a conservative measure. No adverse effects were reported.Additional information is needed to complete the investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915522 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915521 ↗
• MalfunctionSep 28, 2026Mechanical Problem; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915520 ↗
• MalfunctionSep 26, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906836 ↗
• MalfunctionSep 25, 2026No Apparent Adverse Event

  The following has been reported: There is a crack on bottom-left of the front enclosure.A preliminary review of the device logs was not performed.The device was returned for evaluation. The front housing is damaged on the left side bottom corner and extending from the handle assembly to front face. During investigation it was found the cycle counts on the batteries were high (>115). While the batteries are not a source of failure at this time, they will be removed and replaced with new batteries. A broken screw mount was identified. Braided wire was present instead of insulated wire. The bag hook was missing. The lip seals had debris. During repair, the device experience a failing DSPS calibration test (gain out of range). The DSPS sensor was removed and replaced. The DSPS calibration test was performed and the unit passed. After repair, the device passed all functional testing.An active infusion was not stopped. Reporting as a conservative measure for the downstream pressure sensor issue identified during investigation. No adverse effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899074 ↗
• MalfunctionSep 25, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897881 ↗
• MalfunctionSep 25, 2026No Apparent Adverse Event

  The following has been reported: Pump not connected to the network and password not working to login.A preliminary review of the device logs could not be performed.The device was returned for evaluation. The log files indicate a Processor Hardware Failure (Linux Core)/SOM failure. The SOM module will be removed and replaced during the repair process. During evaluation, the (Right/Left/Upper) loading pin assembly was found to have the spring positioned beyond the retaining C-clip. The affected loading pin(s) shall be replaced as part of the repair process.An active infusion was not stopped. Reporting as a conservative measure for the linux core issue identified during investigation. No adverse effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897870 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  The following has been reported:Biomed reported:FK pump (b)(6) was reported with the issue of "pump stating service needed". There were no reports of patient involvement during this case.A preliminary review identified the following issue: Mechanical Hardware Failure (AV Sticky Valve).An active infusion was stopped. Reporting as a conservative measure. No adverse effects were reported.Additional information is needed to complete the investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887835 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887832 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  The following has been reported:Biomed reported: pump problem. No patient harm has occurred, or any active infusion has stopped. A preliminary review identified the following issue: Mechanical Hardware Failure (Air Compressor).An active infusion was stopped. Reporting as a conservative measure. No adverse effects were reported.Additional information is needed to complete the investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887828 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  The following has been reported:Biomed reported: FK pump S/N: (b)(6) was reported with the issue of "says door is open when it is shut". There were no reports of patient involvement during this case.A preliminary review identified the following issue: Mechanical Hardware Failure (AV Sticky Valve)An active infusion was not stopped. Reporting as a conservative measure. No adverse effects were reported.Additional information is needed to complete the investigation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887826 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887823 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  The following has been reported:Biomed reported: Pump serial number (b)(6) with a pin pushed all the way down, cleaned it, but it will not release to the normal position.No patient harm.A preliminary review identified the following issue: Mechanical Hardware Failure (AV Sticky Valve).Unknown if an active infusion was stopped. Reporting as a conservative measure. No adverse effects were reported.Additional information is needed to complete the investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887820 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887816 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887813 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887809 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887806 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887802 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183311. One submission often covers many models, so check the product and lot details in each record.

• Z-2223-2026 · May 6, 2026 · Open, Classified
  LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
• Z-1048-2026 · Nov 21, 2025 · Open, Classified
  Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
• Z-0885-2026 · Nov 14, 2025 · Open, Classified
  Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
• Z-0586-2026 · Nov 3, 2025 · Open, Classified
  IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
• Z-2233-2025 · Jun 24, 2025 · Open, Classified
  LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
• Z-2232-2025 · Jun 24, 2025 · Open, Classified
  LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
• Z-2235-2025 · Jun 24, 2025 · Open, Classified
  LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
• Z-2234-2025 · Jun 24, 2025 · Open, Classified
  LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
• Z-1869-2025 · May 12, 2025 · Open, Classified
  IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
• Z-1019-2025 · Jan 10, 2025 · Open, Classified
  Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through cli
• Z-3153-2024 · Aug 30, 2024 · Open, Classified
  Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
• Z-2721-2024 · Aug 1, 2024 · Open, Classified
  LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
• Z-1484-2024 · Mar 7, 2024 · Open, Classified
  LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
• Z-1283-2024 · May 10, 2023 · Completed
  LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
• Z-1282-2024 · Sep 16, 2022 · Completed
  LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

…and 3 more.