ICU Medical CH-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840619023737), received between Jan 3, 2024 and Sep 8, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677042 ↗
• MalfunctionJun 19, 2025Crack; Crack

  THE EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT WHERE THE CUSTOMER REPORTED THAT THE TECHNICIAN WAS TRYING TO ASPIRATE SOME SOLUTION OUT OF THE BAG (NO DRUG IN IT YET) AND AFTER CONNECTING THE SYRINGE TO THE CIRCLE PRIMING CLAVE PORT, THE CLAVE JUST BROKE OFF COMPLETELY. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN DELAY IN THERAPY BUT NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293320 ↗
• MalfunctionJun 17, 2025No Flow; No Flow

  THE EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT WHERE THE REPORTER STATED THAT THEY WERE UNABLE TO PUSH NORMAL SALINE FLUSH THROUGH CHEMOCLAVE AS IF IT WAS CLOGGED. THERE WAS PATIENT INVOLVEMENT, A DELAY IN THERAPY BUT NO ONE WAS HARMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22238589 ↗
• MalfunctionJan 3, 2024Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  THE COMPLAINT/EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT. A NURSE REPORTED AIR FILLING INTO THE ADDITIVE PORT AND FOUND LEAKAGE OF A CHEMO DRUG AFTER DISCONNECTION. THE PATIENT WAS NOT HARMED, A SPILL KIT WAS USED TO CLEAN THE CHEMO LEAKAGE, AND THE PROCEDURE WAS DELAYED FOR 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441313 ↗

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-3159-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-3161-2026 · May 12, 2026 · Open, Classified
  IV 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-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-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-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-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.