ICU Medical CH3147Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619033941), received between Jun 17, 2024 and Oct 15, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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.

• MalfunctionOct 15, 2025No Flow; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DAY IN AUGUST 2025 IN THE HOSPITAL INVOLVING A 60" (152CM) 0.41 ML, SMALLBORE EXT SET W/CHEMOCLAVE®, SPIROS® W/RED CAP, CLAMP WHERE IT WAS REPORTED THAT THE TUBING WAS LEAKING CHEMO SOMEWHERE NEAR THE SPIROS. THERE WAS PATIENT INVOLVEMENT BUT NO REPORT OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285466 ↗
• MalfunctionJun 17, 2024Leak/Splash; Leak/Splash

  MULTIPLE CHEMO LEAKAGE INCIDENTS WITH USE OF CH3147 60" SMALLBORE EXT. SET WITH MICROCLAVE SPIROS CONNECTIONS. IT WAS REPORTED THAT THERE HAVE BEEN THREE INCIDENTS WHERE CH3147 SET LEAKAGES ORIGINATING "ON OUTSIDE OF SPIROS WHERE BONDED" OCCURRED; THE CHEMO DRUGS WERE IDENTIFIED AS RIMOTECAN AND DOXANUBICIN. NO PATIENT INVOLVEMENT, PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554767 ↗

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-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-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-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-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.