ICU Medical CH3581Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00887709079243), received between Aug 15, 2017 and Aug 22, 2023 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 reports).

7 other recalls cover devices cleared under the same FDA submission (K081361); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE COMPLAINT INVOLVED A ONCOLOGY KIT W/SPINNING SPIROS®, C-CLIP, RED CAP THAT WAS REPORTED TO LEAK CHEMOTHERAPY AT THE CONNECTION OF THE MATING DEVICE'S MALE LUER TO THE SPIROS DURING A PATIENT INFUSION. THE REPORT STATES THAT ON ONE PRIMARY SET WITH THE SPIROS AND COLLAR ATTACHED, THE SPIROS CAME OFF OF THE PRIMARY SET. THERE WAS NO ADVERSE EVENT OR HARM AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595961 ↗
• MalfunctionApr 27, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  A USER FACILITY MANDATORY MEDWATCH WAS RECEIVED THAT STATED, "CYTARABINE PRIMED WITH ALARIS TUBING AND WITH ICU SPINNING SPIROS DEVICE AT THE END CAME DISCONNECTED AT THE POINT OF THE SPIROS, 15 HOURS INTO A 24 HOUR CONTINUOUS INFUSION OF CYTARABINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731881 ↗
• MalfunctionApr 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED ONCOLOGY KIT W/SPINNING SPIROS®, C-CLIP, RED CAP WHICH LEAKED UNSPECIFIED CHEMOTHERAPY ON PATIENT OR HEALTHCARE PROVIDER. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE AND ALL PARTS WERE IN PLACE APPROPRIATELY. NO HOLE, CUT, TEARS OR ANY DEFECT NOTED; IT WAS ALL OVER THE CLOSED BAG SO THE USER COULD NOT FULLY MANIPULATE. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THERE WAS NO BLOOD LOSS OR BLEED BACK. THE DRUG WAS REPLACED AND NO FURTHER ISSUES WERE REPORTED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO ADVERSE OUTCOME AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11723468 ↗
• MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA USER FACILITY MANDATORY MEDWATCH (B)(4) THAT WHILE CHEMOTHERAPY WAS BEING PRIMED IN THE MEDICATION ROOM WITH SPIROS, THE SPIROS "CLICKED" ONTO THE TUBING BUT THE C-CLIP WAS HAVING ISSUES CLICKING. WHEN ATTACHING THE SPIROS TO THE CHEMOTHERAPY, IT STARTED TO BACK PRIME AND LEAKED OUT OF SPIROS. CHEMOTHERAPY WAS RETURNED TO THE PHARMACY. THERE WAS PATIENT INVOLVEMENT THAT RESULTED IN DELAY OF THERAPY. THIS IS REPORT 1 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10972065 ↗
• MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA USER FACILITY MANDATORY MEDWATCH (B)(4) THAT WHILE CHEMOTHERAPY WAS BEING PRIMED IN THE MEDICATION ROOM WITH SPIROS, THE SPIROS "CLICKED" ONTO THE TUBING BUT THE C-CLIP WAS HAVING ISSUES CLICKING. WHEN ATTACHING THE SPIROS TO THE CHEMOTHERAPY, IT STARTED TO BACK PRIME AND LEAKED OUT OF SPIROS. CHEMOTHERAPY WAS RETURNED TO THE PHARMACY. THERE WAS PATIENT INVOLVEMENT THAT RESULTED IN DELAY OF THERAPY. THIS IS REPORT 5 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10972046 ↗
• MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA USER FACILITY MANDATORY MEDWATCH (B)(4) THAT WHILE CHEMOTHERAPY WAS BEING PRIMED IN THE MEDICATION ROOM WITH SPIROS, THE SPIROS "CLICKED" ONTO THE TUBING BUT THE C-CLIP WAS HAVING ISSUES CLICKING. WHEN ATTACHING THE SPIROS TO THE CHEMOTHERAPY, IT STARTED TO BACK PRIME AND LEAKED OUT OF SPIROS. CHEMOTHERAPY WAS RETURNED TO THE PHARMACY. THERE WAS PATIENT INVOLVEMENT THAT RESULTED IN DELAY OF THERAPY. THIS IS REPORT 4 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10972030 ↗
• MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA USER FACILITY MANDATORY MEDWATCH (B)(4) THAT WHILE CHEMOTHERAPY WAS BEING PRIMED IN THE MEDICATION ROOM WITH SPIROS, THE SPIROS "CLICKED" ONTO THE TUBING BUT THE C-CLIP WAS HAVING ISSUES CLICKING. WHEN ATTACHING THE SPIROS TO THE CHEMOTHERAPY, IT STARTED TO BACK PRIME AND LEAKED OUT OF SPIROS. CHEMOTHERAPY WAS RETURNED TO THE PHARMACY. THERE WAS PATIENT INVOLVEMENT THAT RESULTED IN DELAY OF THERAPY. THIS IS REPORT 3 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10971984 ↗
• MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA USER FACILITY MANDATORY MEDWATCH (# 0533050000-2020-8128) THAT WHILE CHEMOTHERAPY WAS BEING PRIMED IN THE MEDICATION ROOM WITH SPIROS, THE SPIROS "CLICKED" ONTO THE TUBING BUT THE C-CLIP WAS HAVING ISSUES CLICKING. WHEN ATTACHING THE SPIROS TO THE CHEMOTHERAPY, IT STARTED TO BACK PRIME, AND LEAKED OUT OF SPIROS. CHEMOTHERAPY WAS RETURNED TO THE PHARMACY. THERE WAS PATIENT INVOLVEMENT THAT RESULTED IN DELAY OF THERAPY. THIS IS REPORT 2 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10971941 ↗
• MalfunctionNov 19, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORTER(B)(4)) WAS RECEIVED WHICH STATED THE FOLLOWING: ¿I WAS PRIMING BUSULFAN FOR A PATIENT WITH IV 3 PORT TUBING AND SPIROS C-CLIP. SPIROS APPEARED TO CONNECT APPROPRIATELY TO END OF TUBING, BLUE SAFETY CLIP SNAPPED IN APPROPRIATELY AS WELL. AFTER I FINISHED CIRCLE PRIMING THE CHEMO I NOTICED IT LEAKING FROM THE POINT WHERE THE SPIROS CONNECTS TO THE TUBING AND IS NOT SUPPOSED TO BE ABLE TO MOVE OR DISCONNECT. I RECHECKED CONNECTION AND CONNECTION SEEMED SECURE AND NOT TO BE MOVING OR TO DISCONNECT IN ANY WAY. I PLACED CHEMO AND TUBING IN CHEMO BAG. SEVERAL MINUTES LATER WHEN OBSERVING LEAK THROUGH CHEMO BAG SPIROS DISCONNECTED COMPLETELY FROM THE IV TUBING.¿ IT WAS ALSO REPORTED THAT THE ORIGINAL INTENDED PROCEDURE WAS PREPARING CHEMO INFUSION AND THAT THE DEVICE FAILED (E.G BROKE, COULDN¿T GET IT TO WORK OR STOPPED WORKING), THE EVENT HAPPENED AT HOSPITAL IN THE PATIENT¿S ROOM AND THE APPROXIMATE AGE OF THE DEVICE WAS 1 DAY. THE EVENT OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871752 ↗
• MalfunctionNov 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORTER # (B)(4) WAS RECEIVED WHICH STATED THE FOLLOWING: ¿WHILE PRIMING THE VINCRISTINE TO AN IV TUBING, I MADE SURE THE BLUE CLIP CLICKED. WHILE PRIMING THE CHEMO, I SAW A SMALL CHEMO LEAKAGE BETWEEN THE CONNECTION OF THE SPIROS CLIP AND THE TIP OF THE IV TUBING. I IMMEDIATELY STOP THE PRIMING AND BROUGHT THE CHEMOTHERAPY TO THE PHARMACY. CHEMO WAS DISPOSED PROPERLY.¿ IT WAS ALSO REPORTED THAT THE ORIGINAL INTENDED PROCEDURE WAS CHEMO INFUSION AND THAT THE DEVICE FAILED (E.G BROKE, COULDN¿T GET IT TO WORK OR STOPPED WORKING), THE EVENT HAPPENED AT HOSPITAL IN THE PATIENT¿S ROOM AND THE APPROXIMATE AGE OF THE DEVICE WAS 1 DAY. THE EVENT OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871748 ↗
• MalfunctionJun 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED AN ONCOLOGY KIT W/SPINNING SPIROS, C-CLIP, RED CAP THAT DISCONNECTED FROM THE BD PUMP SET DURING INFUSION OF VINCRISTINE AND NELARABINE RESULTING IN A LEAK OF MEDICATION. THE EVENT OCCURRED 9 MINUTES INTO THE INFUSION. THE EXACT LOCATION OF THE DISCONNECTION IS THE MALE LUER OF THE BD/CAREFUSION SET CONNECTION TO THE FEMALE LUER CONNECTION OF THE SPIROS. THE MEDICATION CAME INTO CONTACT WITH THE PATIENT OR HEALTH CARE PROVIDED. THE SPILL WAS CLEANED PER FACILITY PROTOCOL. THE SPIROS WAS REPLACED, AND THE DRUG RESUMED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10135650 ↗
• MalfunctionJun 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED AN ONCOLOGY KIT W/SPINNING SPIROS, C-CLIP, RED CAP THAT DISCONNECTED FROM THE BD PUMP SET DURING INFUSION OF VINCRISTINE AND NELARABINE RESULTING IN A LEAK OF MEDICATION. THE EXACT LOCATION OF THE DISCONNECTION IS THE MALE LUER OF THE BD/CAREFUSION SET CONNECTION TO THE FEMALE LUER CONNECTION OF THE SPIROS. THE EVENT OCCURRED BEFORE CONNECTION TO THE PATIENT. THE MEDICATION CAME INTO CONTACT WITH THE PATIENT OR HEALTH CARE PROVIDER. THE CHEMOTHERAPY SPILL WAS CLEANED PER FACILITY PROTOCOL. THERE WAS NO BLOOD LOSS OR BLEED BACK. THE SPIROS WAS REPLACED AND THE DRUG RESUMED. THERE WAS PATIENT INVOLVEMENT BUT NO REPORT OF ADVERSE EVENT.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10135643 ↗
• MalfunctionDec 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A SUS VOLUNTARY MEDWATCH REPORT (#MW5090896) WAS RECEIVED WHICH STATED THE FOLLOWING: "ICU MEDICAL ONCOLOGY KIT WITH SPINNING SPIROS C-CLIP RED CAP WAS USED IN A CLOSED SYSTEM DEVICE ALONG WITH THE BD ALARIS PUMP INFUSION SET TO ADMINISTER CYCLOPHOSPHAMIDE DURING CIRCLE PRIMING, WE NOTICED THAT THERE WAS A LEAK THAT OCCURRED WHERE THE SPIROS CAP AND TUBING JOIN. WE ARE UNSURE IF THIS IS RELATED TO THE TUBING OR THE SPIROS CAP ITSELF. THIS HAS OCCURRED TWO TIMES. WE ARE UNSURE IF THIS IS RELATED TO THE ICU MEDICAL SPIROS CAP OR AN ISSUE WITH THE BD ALARIS PUMP INFUSION SET. FDA SAFETY REPORT ID(S)# (B)(4).¿ THERE IS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT REPORTED. THIS REFLECTS TWO OF TWO EVENTS REPORTED THAT OCCURRED ON AN UNSPECIFIED DATE.

  Patient problems: No Patient Involvement

  MAUDE report 9446979 ↗
• MalfunctionDec 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A SUS VOLUNTARY MEDWATCH REPORT (#MW5090896) WAS RECEIVED WHICH STATED THE FOLLOWING: "ICU MEDICAL ONCOLOGY KIT WITH SPINNING SPIROS C-CLIP RED CAP WAS USED IN A CLOSED SYSTEM DEVICE ALONG WITH THE BD ALARIS PUMP INFUSION SET TO ADMINISTER CYCLOPHOSPHAMIDE DURING CIRCLE PRIMING, WE NOTICED THAT THERE WAS A LEAK THAT OCCURRED WHERE THE SPIROS CAP AND TUBING JOIN. WE ARE UNSURE IF THIS IS RELATED TO THE TUBING OR THE SPIROS CAP ITSELF. THIS HAS OCCURRED TWO TIMES. WE ARE UNSURE IF THIS IS RELATED TO THE ICU MEDICAL SPIROS CAP OR AN ISSUE WITH THE BD ALARIS PUMP INFUSION SET. FDA SAFETY REPORT ID(S)# (B)(4).¿ THERE IS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT REPORTED. THIS REFLECTS ONE OF TWO EVENTS REPORTED THAT OCCURRED ON AN UNSPECIFIED DATE.

  Patient problems: No Patient Involvement

  MAUDE report 9446978 ↗
• MalfunctionNov 20, 2017Connection Problem; Connection Problem

  ETOPOSIDE SPECIAL TUBING CONNECTED TO SPIROS CONNECTOR WAS TRANSFUSING. THE PATIENT OVEREXTENDED AND THE IV TUBING AND THE SPIROS SNAPPED FROM THE CONNECTOR. APPROXIMATELY 15ML OF THE DRUG SPILLED. UNPROTECTED CHEMO EXPOSURE WAS REPORTED.

  Patient problems: Chemical Exposure

  MAUDE report 7044795 ↗
• MalfunctionAug 15, 2017Leak/Splash; Leak/Splash

  COMPLAINT RECEIVED REGARDING ONE CH3581. REPORT STATES: CHEMO LEAK HAPPENED BETWEEN PRIMARY TUBING AND SPIROS. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6794442 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081361. One submission often covers many models, so check the product and lot details in each record.

• Z-3160-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3158-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-1566-2021 · Mar 16, 2021 · Open, Classified
  REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications
• Z-1565-2021 · Mar 16, 2021 · Open, Classified
  REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medicatio
• Z-0701-2021 · Aug 31, 2020 · Open, Classified
  5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (1
• Z-1093-2019 · Feb 21, 2019 · Terminated
  icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanical
• Z-1092-2019 · Feb 21, 2019 · Terminated
  icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanica