ICU Medical CH2000SC-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00840619042769), received between Jul 29, 2019 and Jul 28, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50054350 ↗
• MalfunctionJul 8, 2026

  FLUID WOULD NOT PUSH THROUGH THE PLUNGER; PLUNGER IN SYRINGE PORT GOT STUCK/ WOULD NOT ALLOW FLUID TO PASS. 17 TOTAL DEVICES: LOT NUMBERS INCLUDED: 14925498- X6 SYRINGES: 14988298. 14839655- X3 SYRINGES: 14815765, 14789286, 14813882. 14739286- X2 SYRINGES: 14529298, 14910371.

  Patient problems: Insufficient Information

  MAUDE report 25746916 ↗
• MalfunctionJun 2, 2026

  LOT# 14789286 (5 DEVICES). LOT# 14813882 (1 DEVICE). LOT# 14859143 (2 DEVICE). LOT# 48337157 (1 DEVICE). LOT# 14630129 (1 DEVICE). LOT # 14529298 (1 DEVICE). LOT # 14840353 (1 DEVICE). LOT# 14815765 (1 DEVICE). ISSUES: WOULD NOT LATCH ONTO SYRINGE; PLUNGER INSIDE OF PORT ON CLAVE GOT STRUCK AND WOULD NOT ALLOW FLUID TO PASS HAD TO WASTE THE VIAL; PLUNGER GOT STUCK; PORT WOULD NOT ALLOW FLUID TO BE TRANSFERRED; VIAL OF CYTOXAN HAD TO BE WASTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359729 ↗
• MalfunctionMay 19, 2026

  2 DEVICES - SPIRO WOULD NOT LATCH ONTO SYRINGE; TESTED SYRINGE WITH A NEW SPIRO AND IT DID LATCH. LOT # ON BOTH DEVICES: 14789286.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215944 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  A MEDWATCH WAS RECEIVED WITH REGARDS TO A SPIROS CLOSED MALE LUER IN WHICH IT WAS REPORTED THAT SPIROS CHAMBER FAILED, FILLED WITH DRUG AND SPILLED OUT OF SPIROS BUT DID NOT REACH THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384451 ↗
• MalfunctionDec 16, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  AN EVENT INVOLVED A SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS REPORTED THAT SPIROS BEGAN LEAKING UPON DISCONNECTION. THE EVENT OCCURRED DURING INFUSION. TWO OCCURRENCES WERE REPORTED. NO ADDITIONAL DISTINGUISHING DETAILS OR DIFFERENTIATING INFORMATION WERE PROVIDED. THERE WERE PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824935 ↗
• MalfunctionNov 18, 2025Disconnection; Disconnection

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE (11/1/25 USED AS PLACEHOLDER) AND INVOLVED A SPIROS¿ CLOSED MALE LUER W/RED CAP, (B)(4) UNITS WHERE THE CUSTOMER REPORTED THAT THE DEVICE BECAME DISCONNECTED FROM THE NEEDLELESS CONNECTORS. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587396 ↗
• MalfunctionSep 8, 2025Disconnection; Disconnection

  THE EVENT INVOLVED A SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS. THE REPORTER STATED THAT SPIROS HAS "POPPED OFF" OF THE MEDICATION TUBING, HOWEVER REMAINED ATTACHED TO THE PATIENT'S ACCESS (NEUTRAL OR NEGATIVE PRESSURE CLAVES). MEDICATION INVOLVED IS 5 FU. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998415 ↗
• MalfunctionAug 28, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS GENERATED A DISCONNECTION DURING PATIENT USE. THE REPORTER STATED THAT SPIROS HAS "POPPED OFF" OF THE MEDICATION TUBING; HOWEVER, REMAINED ATTACHED TO THE PATIENT'S ACCESS (NEUTRAL OR NEGATIVE PRESSURE CLAVES). THE MEDICATION INVOLVED IS 5-FU. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916487 ↗
• MalfunctionAug 28, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS, DISCONNECTED DURING PATIENT USE. THE REPORTER STATED THAT SPIROS HAS "POPPED OFF" OF THE MEDICATION TUBING; HOWEVER REMAINED ATTACHED TO THE PATIENT'S ACCESS (NEUTRAL OR NEGATIVE PRESSURE CLAVES). THE MEDICATION INVOLVED IS 5-FU. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916155 ↗
• MalfunctionAug 28, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS, DISCONNECTED DURING PATIENT USE. THE REPORTER STATED THAT SPIROS HAS "POPPED OFF" OF THE MEDICATION TUBING; HOWEVER, REMAINED ATTACHED TO THE PATIENT'S ACCESS (NEUTRAL OR NEGATIVE PRESSURE CLAVES). THE MEDICATION INVOLVED IS 5-FU. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914373 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY 2025 AND INVOLVED A SPIROS¿, CLOSED MALE LUER W/RED CAP, 10 UNITS WHERE IT WAS REPORTED THAT SPIROS LEAKED OUTSIDE OF INTERNAL CHAMBER OF DEVICE. THE EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT BUT THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367370 ↗
• MalfunctionJun 20, 2025Disconnection; Disconnection

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS WHERE IT WAS REPORTED THAT THE CUSTOMER HAD A HANDFUL OF SPIROS DISCONNECTIONS FROM THE END OF SYRINGES/CADD TUBING. THIS ISSUE WAS NOT EVERY DAY BUT OCCASIONALLY. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297855 ↗
• MalfunctionJun 19, 2025No Flow; No Flow

  THE EVENT INVOLVED A SPIROS¿ CLOSED MALE LUER W/RED CAP, 10 UNITS WHERE THE CUSTOMER REPORTED THAT THE DEVICE SOMETIMES DOES NOT FULLY ACCESSING THE CLAVE AND PREVENTS FLOW. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN DELAY IN THERAPY, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293592 ↗
• MalfunctionNov 7, 2024No Flow; No Flow

  A EVENT REGARDING A SPIROS¿, CLOSED MALE LUER W/RED CAP, 10 UNITS EXPERIENCED NO FLOW DURING INFUSION. IT WAS REPORTED: ¿WHILE MAKING A HAZARDOUS CHEMOTHERAPY DRUG. PRIMED THE LINE AND ATTACHED A SPIROS. REGISTERED NURSE (RN) SENT THE MIXTURE BACK FOR OCCLUSIONS HALFWAY THROUGH THE INFUSION. SPIROS WAS FAULTY IF AT A CERTAIN ANGLE IT WOULD ALLOW FLOW BUT IF MOVED IT WOULD NOT CREATED A PROBLEM SINCE THIS ADMIXTURE WAS TIME SENSITIVE AND NEEDED TO BE COMPLETELY INFUSED WITHIN 90 MINUTES. NO PATIENT HARM.¿ ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THE REPORT WAS COMPLETED BY PAMELA HARDING A RISK MANAGER OF HONORHEALTH SCOTTSDALE SHEA MEDICAL CENTER. THE OUTCOME ATTRIBUTED TO ADVERSE EVENT WAS OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS. THIS IS A PRODUCT PROBLEM WITH THE EVENT DATE AUG-2024. THE EVENT OCCURRED IN THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT. MEDWATCH UF/IMPORTER REPORT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20626416 ↗
• MalfunctionNov 6, 2024No Flow; No Flow

  A COMPLAINT WAS RECEIVED REGARDING A SPIROS¿, CLOSED MALE LUER W/RED CAP, 10 UNITS THAT EXPERIENCED OCCLUSION. IT WAS REPORTED THAT, "A REGISTERED NURSE (RN) SENT THE ADMIXTURE BACK TO US SAYING THAT THE LINE WOULD NOT RUN DOWNSTREAM OCCLUSION BROUGHT THE ADMIXTURE BACK UP AND TRIED TO SEE IF THE LINE WOULD FLOW NOTHING WOULD FLOW PAST THE SPIROS. RN HAD TO CHANGE OUT THE LINE COMPLETELY WITH A NEW SPIROS. NO PATIENT HARM." MANUFACTURER RESPONSE FOR SPIROS CAP, SPIROS CLOSED MALE LUER W/RED CAP (PER SITE REPORTER) WAS UNKNOWN. ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THIS WAS A PRODUCT PROBLEM WITH EVENT DATE OF AUG-2024 AND THE EVENT OCCURRED IN THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. MEDWATCH UF/IMPORTER REPORT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625177 ↗
• MalfunctionJun 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP WHERE IT WAS REPORTED THAT DURING AN INFUSION OF IV ARA-C, CHECKED BLOOD RETURN, ATTACHED CHEMO SYRINGE TO IV LINE, PUSHED CHEMO SLOWLY THEN MOM STATED SHE HAD BEEN SPRAYED BY SOMETHING. CHECKED IV LINE, THERE WAS FLUID ON THE OUTSIDE OF THE SPIROS AND MOM AND PATIENT WERE WET. THE SYRINGE STARTED WITH 0.55ML AND WHEN I PUSHED CHEMO, THERE WAS 0.35ML LEFT. MOM AND PATIENT WERE INSTRUCTED TO WASH THEIR HANDS WITH SOAP AND WATER, PHARMACY WAS CALLED AND LOOKED AT THE CHEMO. A NEW SYRINGE OF ARA-C WAS MADE WITH REMAINING DOSE OF 0.35ML PER DOCTOR AND PHARMACY REQUEST. IT WAS NOTED THAT THE LEAK WAS ON THE OUTSIDE OF THE SPIROS THAT WAS ATTACHED TO THE CHEMO SYRINGE. IV CYTARABINE WAS BEING PUSHED THROUGH THE LINE. CHEMO WAS SPRAYED DIRECTLY ONTO THE PATIENT AND MOTHER ON THE ARMS AND HANDS. NO CHEMO WAS FOUND ON THE FLOOR OR ANY OTHER SURFACE. PATIENT AND MOTHER WERE ADVISED TO WIPE SKIN FIRST TO ABSORB ANY CHEMO ON SKIN, THEN WASH HANDS/ ARMS WITH WARM SOAPY WATER. SYRINGE WAS PREPARED BY CENTRAL PHARMACY AND SENT UP TO UNIT WITH SPIROS ALREADY ATTACHED. THE CHEMO SYRINGE WAS THEN ATTACHED TO A CHEMO SYRINGE TUBING WHICH

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

  MAUDE report 19466494 ↗
• MalfunctionMar 14, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT A SPIROS¿, CLOSED MALE LUER W/RED CAP, 10 UNITS VIA MEDWATCH UF/IMPORTER REPORT # (B)(4) THAT THE "SPIROS DID NOT LOCK ONTO SYRINGE AND WAS POPPED OFF; DID NOT REACH THE PATIENT." THE EVENT OCCURRED IN THE HOSPITAL. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT OR STAFF HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909681 ↗
• MalfunctionNov 2, 2023No Flow; No Flow

  THE EVENT INVOLVED A SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS WHERE THE CUSTOMER REPORTED THAT THE CLOSED SYSTEM TRANSFER DEVICE DID NOT ALLOW FLUID MOVEMENT. AFTER MULTIPLE ATTEMPTS, A REPLACEMENT WAS USED AND WORKED CORRECTLY. THERE WAS PATIENT INVOLVEMENT BUT NO HARM TO PATIENT OR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18053747 ↗
• MalfunctionOct 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY MANDATORY MEDWATCH REPORT WAS RECEIVED ON 17-SEP-2021 STATING THAT MEDICATION CAME FROM THE PHARMACY WITH TUBING HAVING A POOR CONNECTION TO THE SPIROS DEVICE BEING USED DURING THE EVENT. THIS CAUSED THE MEDICATION TO LEAK OUT FROM IT WHEN HOOKED UP TO THE IV PUMP. VIDAZA LEAKED THROUGH THE TUBING SITE THAT WAS CONNECTED TO THE SPIRO. THERE WERE NO INJURIES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598988 ↗
• MalfunctionMar 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A MEDSUN MANDATORY MEDWATCH REPORT WAS RECEIVED THAT STATED, "PATIENT WAS RECEIVING VIDAZA INJECTION WITH CLOSED-SYSTEM TRANSFER DEVICE ATTACHED TO THE END OF THE SYRINGE. NURSE MET RESISTANCE WITH VIDAZA AND WHILE ATTEMPTING TO PUSH THE DRUG, VIDAZA SPRAYED OUT OF THE CLOSED-SYSTEM TRANSFER DEVICE SPRAYING ONTO NURSE AND PATIENT." ADDITIONALLY, THE CUSTOMER STATED THE ONLY SET UP NURSING DID WAS ATTACH THE NEEDLE TO SPIROS AND THERE WERE NO ISSUES DURING PRIMING/SET-UP OF THE SYRINGE IN QUESTION. THE LOCATION WHERE LEAKAGE WAS OBSERVED WAS IN THE MIDDLE OF THE DEVICE. THE INSIDE TUBE SEEMED TO RUPTURE AND CLEAR FLUID FILLED THE OUTER WALLS FROM THE INSIDE. THERE WERE NO OBSERVED COMPONENT DAMAGES AND ANOMALIES, THEY COULD ONLY SEE THE CLEAR FLUID (MEDICATION). THE ORIGINAL PROCEDURE WAS TO ADMINISTER VIDAZA. THE EVENT OCCURRED IN AN OUTPATIENT TREATMENT FACILITY. THERE WAS PATIENT INVOLVEMENT AND NO REPORT OF HUMAN HARM.

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

  MAUDE report 11473394 ↗
• MalfunctionNov 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS THAT LEAKED WITH A DOXORUBICINE IV PUSH SYRINGE ON THE LOWER Y-SITE OF A PRIMARY IV TUBING SET. THE CLINICIAN STATED THAT INITIALLY, THERE WERE NO ISSUES, BUT WHEN SHE WAS CHECKING FOR BLOOD RETURN, IT BECAME SOMEWHAT DIFFICULT TO PULL AND SUBSEQUENTLY PUSH THE REMAINING DRUG INTO THE PATIENT AND SHE THEN NOTICED THAT THE SPIROS WAS LEAKING AT THE CONNECTION OF THE VALVE ON THE PRIMARY SET AND THE SPIROS. CHEMOTHERAPY THEN LEAKED ONTO THE FLOOR AND THE CLINICIAN¿S LEG. THERE WAS NO PATIENT HARM NOR ADVERSE EVENT REPORTED.

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

  MAUDE report 10880108 ↗
• MalfunctionNov 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON UNSPECIFIED DATES AND INVOLVED AT LEAST A DOZEN SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS THAT HAD LEAKS OF VARIOUS, MULTIPLE CHEMO INFUSIONS OCCURRING AT THE SPIROS AT THE DISTAL END OF THE AMBULATORY PUMP TUBING, AND THE CONNECTION TO THE PATIENT. THE LEAKING OCCURRED AT THE INFUSION SUITE AND THE PATIENT EXPERIENCED THE FLUID GETTING ON THEM. THE CUSTOMER REPORTED THAT THE CHEMO BAGS COME OUT PRIMED FROM THE PHARMACY, SO MOST LIKELY, THE EVENT OCCURRED DURING HOOK-UP, OR INFUSION. THE CUSTOMER REPORTED THE POSSIBLE MATING DEVICES WERE A CLAVE CONNECTOR, OR SAFE DAY EXTENSION SET. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL, AND NEW BAGS WERE MADE, THERAPY RESUMED, AND NO SPIROS WERE ATTACHED TO REPLACEMENTS. THERE WERE NO HOLES, CUTS, TEARS, OR ANY DEFECTS NOTED ON THE DEVICE. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT.

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

  MAUDE report 10833117 ↗
• MalfunctionNov 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE, AND INVOLVED SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS. IT WAS REPORTED THAT A SPIROS THAT WAS LEAKING AN UNSPECIFIED CHEMOTHERAPY MEDICATION. THERE IS NO REPORT OF ADVERSE EVENT, OR PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10823109 ↗
• MalfunctionJul 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPIROS CLOSED MALE LUER W/RED CAP THAT LEAKED AN UNSPECIFIED CHEMOTHERAPY DURING AN INTRAVENOUS PUSH. THE CHEMOTHERAPY COMPLETELY COVERED THE PATIENT. THERE IS PATIENT INVOLVEMENT WITH AN UNSPECIFIED ADVERSE EVENT, BUT NO DELAY IN THERAPY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE SECOND OF TWO EVENTS.

  Patient problems: Chemical Exposure

  MAUDE report 10272022 ↗

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