ICU Medical CH2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619023782), received between Jul 18, 2024 and Sep 16, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794642 ↗
• MalfunctionJul 18, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE REPORT STATED THAT THEY WERE EXPERIENCING LEAKING/DISCONNECTION ISSUES WITH THEIR SPIROS CONNECTORS. MOST RECENTLY AT THEIR (B)(6). A SPIROS STARTED LEAKING/UNSCREWING FROM A PATIENT¿S TUBING AT A DIFFERENT LOCATION THAN BEFORE (WHERE THE DEVICE IS NOT EVEN SUPPOSED TO UNSCREW).THE NURSE ATTACHED THE SPIROS HERSELF TO THE END OF THEIR IV TUBING, AS THEY HAVE ALWAYS DONE WHEN THEY HAVE AN ONCOLOGY DRUG THAT WILL RUN THROUGH THE TUBING. THE NURSE DID HEAR THE CLICK THAT THE SPIROS WAS CONNECTED PROPERLY TO THE TUBING. THE NURSE STARTED THE DRUG AND THE PATIENT CALLED OUT SAYING SOMETHING WAS LEAKING. ON INSPECTION, THE NURSE SAW THE LEAK WAS COMING FROM BETWEEN THE ATTACHMENT OF THE SPIROS AND THE BD MAX ZERO END CAP. SHE STOPPED THE DRUG, DISCONNECTED THE SPIROS AND DRIED THE END CAP OFF AS SHE WAS INSTRUCTED TO DO BY THE REPRESENTATIVE WHEN THEY VISITED THE DEPARTMENT. THE NURSE RECONNECTED THE SPIROS TO THE MAX ZERO END CAP AND WHILE DOING THAT, THE OTHER END OF THE SPIROS BECAME DISCONNECTED FROM THE IV TUBING. THE CUSTOMER ASKED THE NURSE IF SHE WAS SURE THE SPIROS WAS CONNECTED TO THE TUBING CORRECTLY AND SHE SAID YES, IT WAS SPINNING AND NOT ABLE TO BE UNSCREWED. SO A LITT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19777342 ↗

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-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-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-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-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-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-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.