ICU Medical CL4180Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709123878), received between Feb 7, 2025 and Apr 2, 2025 — classified as 3 malfunctions.

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

60 other recalls cover devices cleared under the same FDA submission (K131549); 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.

• MalfunctionApr 2, 2025Material Separation; Material Separation

  IT WAS REPORTED VIA MEDWATCH REPORT (B)(4) THAT THE PATIENT WAS ADMITTED TO BONE MARROW TRANSPLANT UNIT ON (RETRACTED DATE). NEW IV LINES WERE MADE WITH A QUADFUSE THAT HAD BONDED CHEMOLOCK ON ONE ARM. THE NURSE FOUND THE LUER LOCK HAD DISCONNECTED FROM THE QUAD FUSE. THE LUER LOCK REMAINED ON THE PATIENT'S MICROCLAVE CAP CLOSEST TO THE PATIENT WHILE THE QUAD FUSE WAS LAYING ON THE BED. THERE WAS BLOOD LOSS. THE NURSE WAS UNSURE OF THE AMOUNT OF THE BLOOD LOSS. THE ORIGINAL INTENDED PROCEDURE WAS IV CHEMOTHERAPY DELIVERY. THE PROBLEM OF THE USER WAS THE DEVICE FAILED. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT WAS CHEMOTHERAPY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759071 ↗
• MalfunctionMar 26, 2025Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem

  THE EVENT INVOLVED A 10" (25 CM) APPX 2.6 ML, EXT SET, QUADFUSE W/3 CLAVE¿ CLEAR, CHEMOLOCK¿ PORT, 5 CLAMPS (3 WHITE, 1 BLUE, 1 RED), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THEY HAVE HAD INCIDENT REPORTS OF QUADFUSE BREAKING OFF FROM THE LUER CONNECTION. ALL THE BREAKS HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, CHEMO SPILLS, AND CAN POTENTIALLY CAUSE GREAT HARM FOR THE PATIENTS. THE CUSTOMER STATED THAT THERE WERE MANY INCIDENCES OF BROKEN EQUIPMENT BUT THEY ARE UNABLE TO GIVE ACCURATE INFORMATION ABOUT WHICH BROKEN EXTENSION TUBING (BI/TRI/QUAD FUSE) HAD HARM; THE CUSTOMER FURTHER STATED THAT MOST DID HAVE SOME HARM IN BLOOD LOSS BUT THE VOLUME OF BLOOD LOSS WAS NOT ABLE TO BE OBTAINED. THE CUSTOMER STATED THAT THE MAJORITY OF THE BLOOD LOSS WAS NOT SUBSTANTIAL ENOUGH TO REQUIRE BLOOD TRANSFUSION. THERE MAY HAVE BEEN SOME CHEMO EXPOSURE, BUT NONE REQUIRED EMERGENT CARE OR TREATMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699474 ↗
• MalfunctionFeb 7, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO 10" (25 CM) APPX 2.6 ML, EXT SET, QUADFUSE W/3 CLAVE¿ CLEAR, CHEMOLOCK¿ PORT, 5 CLAMPS (3 WHITE, 1 BLUE, 1 RED), LUER LOCK THAT EXPERIENCED BREAKAGE AND LEAKAGE DURING USE. THE REPORTER STATED THAT "ALL THE BREAKS HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THEY THINK IT MAY BE A BONDING ISSUE. THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, CHEMO SPILLS, AND CAN POTENTIALLY CAUSE GREAT HARM FOR THE PATIENTS." "PATIENTS DID NOT SUFFER HARM AS THESE WERE FOUND QUICKLY, BUT THE PATIENT¿S DID LOSE BLOOD AND CHEMO WAS ALSO SPILLED".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21339788 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131549. 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-2210-2026 · Mar 24, 2026 · Open, Classified
  Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL
• Z-0355-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
• Z-0351-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
• Z-0345-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
• Z-0342-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
• Z-0353-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
• Z-0338-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
• Z-0339-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
• Z-0347-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
• Z-0361-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
• Z-0350-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port REF: CL2100
• Z-0344-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
• Z-0332-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011

…and 45 more.