Ivenix Infusion SystemRecalls & reported problems across all models

We found 5 models of Ivenix Infusion System by Fresenius Kabi AG in the FDA's device registry (GUDID). Together they are named in 4,736 adverse event reports in the FDA's MAUDE database, received between May 13, 2024 and Sep 30, 2026 — classified as 2 deaths, 21 injuries, 4,713 malfunctions.

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

9 FDA recall records name at least one of these models by its device identifier, 9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Ivenix Infusion System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 6, 2026Open, 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, 2026Open, Classified

   Potential for the Cassette Loading Lever to break.

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

3. Nov 3, 2025Open, Classified

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

   Z-0586-2026 · Root cause: Process control · Recall details · FDA record ↗

4. Nov 3, 2025Open, 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 ↗

5. Sep 3, 2025Open, 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 ↗

6. Jun 24, 2025Open, Classified

   Potential for external cassette leaks

   Z-2235-2025 · Root cause: Process design · Recall details · FDA record ↗

7. Dec 6, 2024Open, 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 ↗

8. Nov 29, 2023Open, 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 ↗

9. Mar 10, 2023Open, 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 Ivenix Infusion System problems

Ivenix Infusion System models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Ivenix Infusion System LVP-0004

  Pump, Infusion
  7 recalls2 deaths4,328 reports
• Ivenix Infusion System SET-0032-1

  Set, Administration, Intravascular
  2 recalls396 reports
• Ivenix Infusion System 030-0028-08

  Pump, Infusion
  7 reports
• Ivenix Infusion System 030-0027-06

  Infusion Safety Management Software
  3 reports
• Ivenix Infusion System 030-0028-07

  Pump, Infusion
  2 reports

Recent Ivenix Infusion System adverse event reports

The 15 most recent reports across all models, 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, 2026Leak/Splash; No Apparent Adverse Event; Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915527 ↗
• MalfunctionSep 28, 2026Leak/Splash; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915526 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915525 ↗
• MalfunctionSep 28, 2026Leak/Splash; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915524 ↗
• 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 ↗

Other Fresenius Kabi AG products

• Ivenix, Inc.4 models · 211 reports · 15 recalls
• Volumat Line8 models · 49 reports