ICU Medical CH4002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840619054786), received between Jul 3, 2024 and Sep 15, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

9 other recalls cover devices cleared under the same FDA submission (K173477); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766105 ↗
• MalfunctionNov 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING A 46 50 ML DILUENT SET FOR CHANNEL 2, SPIROS, ALLEGING A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THERE WAS LEAKAGE FROM THE SPIROS. THE EVENT WAS NOTED DURING INFUSION. MORIAMIN-SN WAS INVOLVED IN THE EVENT. THERE WAS NO BLEEDBACK REPORTED. THE PRODUCT IS NOT A BIOHAZARD, AND THE DEVICE WAS NOT REPROCESSED/RESTERILIZED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THERE WAS NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507072 ↗
• MalfunctionNov 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING A 46 50 ML DILUENT SET FOR CHANNEL 2, SPIROS, ALLEGING A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THERE WAS LEAKAGE FROM THE SPIROS. THE EVENT WAS NOTED DURING INFUSION. MORIAMIN-SN WAS INVOLVED IN THE EVENT. THERE WAS NO BLEEDBACK REPORTED. THE PRODUCT IS NOT A BIOHAZARD, AND THE DEVICE WAS NOT REPROCESSED/RESTERILIZED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THERE WAS NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507064 ↗
• MalfunctionJul 3, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE EVENT INVOLVED A 46" (117 CM) 50 ML, DILUENT SET FOR CHANNEL 2 W/20 DROP DRIP CHAMBER, SPIROS® WHERE IT WAS REPORTED THE SYRINGE CONTAINS IMPURITIES, WHICH ARE PRESENT DUE TO THE COLOR DISCREPANCY BETWEEN THE CONNECTOR AND THE IMPURITIES, INDICATING CONTAMINATION FROM NON-USE." THE EVENT OCCURRED DURING MEDICATION PREPARATION. IT WAS ALSO MENTIONED THAT THERE WAS NO CONCOMITANT DRUG, NO CONCOMITANT DEVICE, NO BLEED-BACK, WITH UNKNOWN NAME OF CHEMO DRUG, NO BIO-HAZARD AND UNKNOWN USER FACILITY MED-WATCH. THE DEVICE WAS NOT REPROCESSED/RESTERILIZED. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665335 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173477. One submission often covers many models, so check the product and lot details in each record.

• Z-3161-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3159-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-1579-2021 · Mar 16, 2021 · Open, Classified
  REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a
• Z-1577-2021 · Mar 16, 2021 · Open, Classified
  REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the adm
• Z-1576-2021 · Mar 16, 2021 · Open, Classified
  REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the adm
• Z-1578-2021 · Mar 16, 2021 · Open, Classified
  REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration o
• Z-1580-2021 · Mar 16, 2021 · Open, Classified
  REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administrat
• Z-0704-2021 · Aug 31, 2020 · Open, Classified
  3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinn
• Z-0248-2021 · Jul 6, 2020 · Terminated
  6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149.