ICU Medical CH3955Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887709098305), received between Jun 12, 2025 and Aug 27, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026No Flow

  The event involved a ChemoClave Bag Spike with Additive Port, ChemoClave reported that when spiking the ifosfamide bag to Circle Prime, the clave depressed and malfunctioned, and no fluid was able to leave the IV bag into the tubing. Pharmacy re-made the dose due to the spike malfunction, and the same thing happened a second time. The bag spike depressed too far, and no fluid was able to flow from the bag. The event occurred during patient use. There was a delay in therapy. There was patient involvement and no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50475541 ↗
• MalfunctionAug 24, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50417283 ↗
• MalfunctionAug 7, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177727 ↗
• MalfunctionAug 22, 2025No Flow; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOCLAVE¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOCLAVE¿. IT WAS REPORTED THAT CHEMOTHERAPY WOULD NOT FLOW AFTER IT HAS BEEN SPIKED BY PHARMACY, SEEMING LIKE THE VERTICAL CLAVE WAS COMPRESSED. MULTIPLE EVENTS OCCURRED THROUGHOUT JULY AND THIS WEEK. THE CHEMO DID COME INTO CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THERE WAS AN UNSPECIFIED DELAY IN PATIENT CARE; INCREASED TIME/SCRAMBLING WITH NURSING AND PHARMACY TO RE-SPIKE THE BAG. THE STAFF REPORTED A SAFETY CONCERN WITH MORE MANIPULATION TRYING TO GET IT TO WORK. INCREASE IN CENTRAL LINE ACCESS. THERE WAS NO SPILL. THE ISSUE OCCURRED DURING USE ON PATIENTS. THERE WAS NO ADVERSE EVENT OR HUMAN HARM.

  Patient problems: Chemical Exposure

  MAUDE report 22877241 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE REPORTED COMPLAINT INVOLVED A CHEMOCLAVE¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOCLAVE¿. THE REPORTER ORIGINALLY STATED THAT A SPIROS BROKE WHILE A NURSE WAS HANDLING ICU MEDICAL PRODUCT PRIOR TO GIVING AN UNSPECIFIED CHEMOTHERAPY DRUG TO THE PATIENT AND THE CHEMO SPILLED ALL OVER THE NURSE. ADDITIONAL INFORMATION WAS SUBSEQUENTLY PROVIDED BY THE CUSTOMER REFERRING TO THE POSSIBLE LIST NUMBER OF CH3955. THERE WAS NO OTHER CLINICAL CONSEQUENCE TO THE NURSE OR THE PATIENT REPORTED.

  Patient problems: Chemical Exposure

  MAUDE report 22323139 ↗
• MalfunctionJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE(S) BETWEEN LATE APRIL THROUGH MAY AND INVOLVED A CHEMOCLAVE¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOCLAVE¿ WHERE THE CUSTOMER REPORTED THAT THERE HAVE BEEN EVENTS OF LEAKING. THE CUSTOMER STATED THAT THE LEAKAGE WAS NOTED AT CONNECTION POINT OF BLUE PORT AND WHITE BODY OF CHEMOCLAVE AND THAT THE UNSPECIFIED CHEMOTHERAPY ADMINISTRATION WAS DELAYED. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, HARM WAS NOT REPORTED AS A CONSEQUENCE OR THE EVENT(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294512 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE IN LATE APRIL, A CHEMOCLAVE¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOCLAVE¿ GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THERE HAVE BEEN EVENTS OF STICK DOWN AND LEAKS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196010 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE IN MAY, A CHEMOCLAVE¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOCLAVE¿ GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THERE HAVE BEEN EVENTS OF STICK DOWN AND LEAKS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196003 ↗

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-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-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-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-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.