ICU Medical CL3534Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709057067), received between Jul 12, 2017 and Sep 11, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED AN ADAPTOR SPIKE CHEMOLOCK BAG WHERE IT WAS REPORTED THE CHEMOLOCK CRACKED AND STARTED LEAKING DOXORUBICIN DURING A MEDICATION PUSH. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028149 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 5" (13 CM) APPX 1.8 ML, BAG SPIKE ADAPTER W/CHEMOLOCK¿ W/RED CAP, VENTED CAP WHERE IT WAS REPORTED THAT THE CHEMO SPIKE ADAPTOR WAS LEAKING CHEMO AFTER THE PUMP STARTED. THERE WAS UNEXPECTED OR PROLONGED CARE, AND THE SAMPLE WAS WIPED, DOUBLED BAGGED (IF CONSUMABLE), AND LABELLED AS PER INSTRUCTIONS. THERE WAS PATIENT INVOLVEMENT AND THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21377287 ↗
• MalfunctionJan 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 5" (13 CM) APPX 1.8 ML, BAG SPIKE ADAPTER W/CHEMOLOCK¿ W/RED CAP, VENTED CAP WHERE THE CUSTOMER REPORTED THAT THE CHEMO LINE (BAG SPIKE ADAPTER W CHEMO LOCK) WAS FAULTY AND STARTED LEAKING CHEMOTHERAPY MEDICATION (UNSPECIFIED) WHEN WRITER STARTED TO CIRCLE PRIME THE LINE. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246504 ↗
• MalfunctionNov 7, 2024Material Separation; Material Separation

  A COMPLAINT WAS RECEIVED REGARDING A 5" (13 CM) APPX 1.8 ML, BAG SPIKE ADAPTER W/CHEMOLOCK¿ W/RED CAP, VENTED CAP DISCONNECTED DURING INFUSION. THE REPORT STATED THAT THE CHEMO BAG ADAPTER DISCONNECTED WHEN WRITER ATTEMPTED TO DISCONNECT FROM BAG TO SAVE TUBING. THE EVENT OCCURRED ON 24-SEP-2024. THE TYPE OF INCIDENT/PROBLEM IS CONNECTION PROBLEM, AND THE FREQUENCY OF PROBLEM IS RECURRING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM OR ADVERSE EVENT. IN ADDITION, IT WAS REPORTED TO CMDSNET (HEALTH CANADA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631245 ↗
• MalfunctionAug 23, 2017Leak/Splash; Leak/Splash

  COMPLAINT RECEIVED REGARDING ONE CL3534. REPORT STATES: THERE WAS A CHEMOTHERAPY LEAK AT THE CONNECTION OF THE PRODUCT IDENTIFIED ABOVE AND THE SECONDARY SET, CL3520. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6813144 ↗
• MalfunctionJul 12, 2017Leak/Splash; Leak/Splash

  CHEMOLOCK ADAPTER USED AS PART OF BAXTER IV ADMINISTRATION SET FOR CIRCLE PRIMING AND ADMINISTRATION OF CHEMOTHERAPY. CHEMOTHERAPY INFUSION WAS DISCOVERED TO BE LEAKING, SPECIFICALLY THE CHEMOTHERAPY ADAPTER, APPROXIMATELY 5 MINUTES INTO CHEMOTHERAPY INFUSION. PRODUCT REACHED PATIENT, NO APPARENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6708918 ↗

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-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-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-0353-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
• Z-0341-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike REF: CL-10
• Z-0334-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: C
• Z-0356-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
• Z-0328-2026 · Sep 8, 2025 · Open, Classified
  ChemoLock Bag Spike, 01 units REF: CL-10-10
• Z-0340-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
• Z-0347-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
• Z-0335-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
• Z-0351-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
• Z-0350-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port REF: CL2100
• Z-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• 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

…and 45 more.