Ivenix Infusion System 030-0028-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811505030436), received between Oct 30, 2024 and Nov 6, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

25 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Computer Software Problem; No Apparent Adverse Event; Computer Software Problem; No Apparent Adverse Event

  THE DEVICE TRIGGERED A PUMP PROBLEM ALARM INSTEAD OF A TUBING SET MISLOADED ALERT. THE COMBINATION OF RAPID UNLOADING AND RELOADING OF AN ADMIN SET, WITH THE SET MISLOADED IN SUCH A WAY THAT THE RESISTOR IS UNABLE TO COUPLE, CAN LEAD TO THE START BUTTON NO LONGER BEING GRAYED OUT. PROGRAMMING AN INFUSION AND PRESSING ON THE START BUTTON AS THE PUMP IS TRYING TO COUPLE WITH THE ADMIN SET CAN RESULT IN A COHERENCE FAILURE, TRIGGERING A PUMP PROBLEM ALARM. THE DEFECT RISK ASSESSMENT DETERMINED THE RISK AND SEVERITY TO BE A 1 - INCONVENIENCE. NO FURTHER ACTION IS PLANNED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623048 ↗
• MalfunctionOct 30, 2024No Apparent Adverse Event; No Apparent Adverse Event

  REVIEWING THE SOURCE CODE SHOWED THAT THE ROOT CAUSE OF THE PROBLEM WAS A TIMING ISSUE THAT COULD OCCUR IF THE USER WERE TO START THE SECONDARY INFUSION JUST AS THE PRIMARY INFUSION WAS TRANSITIONING TO KVO. A FIX WAS IMPLEMENTED THAT ENSURES THAT THE PRIMARY IS NOT SET TO FOLLOW IF IT TRANSITIONS INTO KVO AND FOLLOW UP TESTING HAS CONFIRMED THAT THIS FIX WAS SUCCESSFUL. THIS WILL BE A PART OF THE NEXT SW RELEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571410 ↗

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-2224-2026 · May 6, 2026 · Open, Classified
  Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
• Z-2223-2026 · May 6, 2026 · Open, Classified
  LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
• Z-2274-2026 · Feb 4, 2026 · Open, Classified
  The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
• 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-0848-2026 · Nov 3, 2025 · Open, Classified
  Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
• Z-0378-2026 · Sep 3, 2025 · Open, Classified
  Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
• 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-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-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-0763-2025 · Dec 6, 2024 · Open, Classified
  Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

…and 10 more.