ICU Medical CH3367Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840619060657), received between Jun 16, 2024 and Jun 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K070532); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025No Flow; No Flow

  THE EVENT INVOLVED AN 8" (20 CM) APPX 0.43 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS, SPIROS¿ WHERE THE CUSTOMER STATED THAT THE DEVICE WAS PREVIOUSLY RUNNING CHEMOTHERAPY AND FLUIDS, AND WHEN THE NURSE WENT TO CHECK BLOOD RETURN IN BETWEEN CHEMOTHERAPIES, THE NURSE WAS ABLE TO OBTAIN BLOOD RETURN BY PULLING BACK ON A SYRINGE BUT UNABLE TO FLUSH ANYTHING. THE NURSE DISCONNECTED THE Y-SITE TUBING FROM THE PATIENT. THE PATIENT'S LINE WAS WORKING FINE, WITH GOOD BLOOD RETURN. THERE WAS NO PATIENT HARM OR ADVERSE EVENT AS A RESULT OF THIS EVENT. A MDR REPORT #MW5169769 WAS RECEIVED ON 14-MAY-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201803 ↗
• MalfunctionJul 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AN 8" (20 CM) APPX 0.43 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS, SPIROS¿ GENERATED A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT A Y SITE INFUSING ANTIBIOTIC BLOOD BACKED UP TO THE BLUE PART OF THE Y SITE AND WAS LEAKING ONTO THE BED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823168 ↗
• MalfunctionJun 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, AN 8" (20 CM) APPX 0.43 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS, SPIROS¿ GENERATED A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT AS THE REGISTERED NURSE (RN) WENT TO HOOK UP THE FLUSH, THE LOCK ENGAGED, AND BLOOD STARTED POURING OUT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19545026 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070532. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2021 · Aug 31, 2020 · Open, Classified
  42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, RE