ICU Medical CH2000S-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 249 adverse event reports that list this exact device (DI 00840619026615), received between Jul 24, 2017 and Sep 23, 2026 — classified as 249 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (194 reports).

5 other recalls cover devices cleared under the same FDA submission (K082806); 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 249 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Disconnection; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873173 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  The event involved a Spinning Spiros Closed Male Luer, Red Cap reported that after the spiros was attached and twisted until "clicked", the spiros became detached. This was a securement device and should never disconnect. There were no patient harm and no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871265 ↗
• MalfunctionSep 23, 2026Disconnection

  The event involved a Spinning Spiros Closed Male Luer, Red Cap. It was reported that spiros sounded as if it was clicked onto primary tubing, but when staff double checked, they were able to completely pull the spiros off the tubing. The event occurred Prior to patient use, connecting to primary tubing. There was no delay in therapy. Sample was retained with no contaminants. The outcome of the event was new supplies obtained, treatments provided There were no patient involvement and harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869584 ↗
• MalfunctionSep 21, 2026Disconnection; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845675 ↗
• MalfunctionSep 21, 2026Disconnection; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843726 ↗
• MalfunctionSep 21, 2026Disconnection; Fluid/Blood Leak

  Additional used device has been received for the investigation and a reported incident involving a Spinning Spiros Closed Male Luer, Red Cap. It was reported that Spiros did not securely attach to tubing, fell off. Spiros became detached during IV push medication administration via syringe through a peripheral and central line, which resulted in Chemo spill, lost drug, and drug contamination. Although there was patient involvement, no patient harm occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843453 ↗
• MalfunctionSep 21, 2026Disconnection; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843445 ↗
• MalfunctionSep 16, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792016 ↗
• MalfunctionSep 16, 2026Disconnection

  A reported incident involving a Spinning Spiros Closed Male Luer, Red Cap. It was reported that when attaching the spiros to the primary tubing, the spiros acted as if it clicked on. When double checking it was secure, the registered nurse was able to pull it off the tubing. The event occurred prior to patient use after priming tubing. There was no patient involvement or harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791732 ↗
• MalfunctionSep 11, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741152 ↗
• MalfunctionAug 26, 2026Fluid/Blood Leak; Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459270 ↗
• MalfunctionAug 25, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439123 ↗
• MalfunctionAug 25, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50433655 ↗
• MalfunctionAug 20, 2026Disconnection; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354280 ↗
• MalfunctionAug 20, 2026Disconnection; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354259 ↗
• MalfunctionAug 18, 2026Disconnection; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50300883 ↗
• MalfunctionJul 27, 2026Disconnection

  A reported incident involving a Spinning Spiros Closed Male Luer, Red Cap, Spiros connector failed during a Blincyto (blinatumomab) infusion. The Spiros was observed to have become disconnected from the tubing connection site. The patient's caregiver reported that the connector "fell off." Attempts by the nurse to reconnect the Spiros were unsuccessful, as the connector continued to rotate and would not attach to the tubing luer lock. The event occurred during therapy. There were no reported patient involvement and no injury or adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50011434 ↗
• MalfunctionJun 21, 2026Complete Blockage

  THE EVENT INVOLVED DESCRIPTION OF PRODUCT: RED CAP CONNECTOR W/NEEDLE LOCK WITH CAP. GRM 11911607. THE PROBLEM: THEY CONNECT TO THE CONNECTOR VIA CHEMOTHERAPY TUBING. THEN THEY SCREW IT ONTO THE INFUSION PUMP. IN BCE ONCOLOGY, WHEN STARTING THE PUMP, A BLOCKAGE OCCURS. RETRO PURGE IMPOSSIBLE AND TREATMENT INFUSION IMPOSSIBLE. THE PRODUCT IS USED WITH THE PLUM 360 PUMP AND THE TUBING ADMINISTRATION FOR INFUSION PUMP 262 CM (103) IC14687-28 (OUR GRM 11015875). THE SAMPLE IS AVAILABLE TO SEND FOR EVALUATION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572594 ↗
• MalfunctionJun 4, 2026Disconnection

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A SPINNING SPIROS CLOSED MALE. IT WAS REPORTED THAT THE DEVICE WAS USED AT THE END OF A CADD RESERVOIR PUMP LINE. IN TWO OCCURRENCES INVOLVING THE SAME PATIENT, THE ADAPTER APPEARED TO GENERATE EXCESSIVE PRESSURE WHEN CONNECTING, CAUSING THE LINE TO DISLODGE FROM THE SITE. DURING THE FIRST INSTANCE, THE PHARMACY REPLACED THE LINE AND ADAPTER, AND THE INFUSION WAS SUCCESSFULLY COMPLETED. IN THE SUBSEQUENT OCCURRENCE, MULTIPLE ATTEMPTS TO REPLACE THE LINE AND ADAPTER WERE UNSUCCESSFUL, LEADING TO REMOVAL OF THE SPIROS DEVICE, AFTER WHICH THE INFUSION WAS COMPLETED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389590 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak; Separation Problem

  AN EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP, WHERE IT WAS REPORTED THAT THE SPIROS WERE ATTACHED TO THE LINE AND CONNECTED TO THE PATIENT FOR AN HOUR. WHEN THE PATIENT LEANED FORWARD, THEY NOTICED FLUID DRIPPING ON THEM. THE SPIROS WAS STILL CONNECTED TO THE CLAVE ON THE PORT, BUT THE LINE ITSELF WAS DISCONNECTED FROM THE SPIROS. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

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

  MAUDE report 24494304 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  THE EVENT INVOLVED SPINNING SPIROS, AND IT WAS REPORTED THAT A SPIROS DETACH FROM A PRIMARY LINE, CAUSING MEDICATION TO LEAK. THE DRUG LEAKED ONTO THE PATIENT¿S CLOTHES, MAINLY ON HER ABDOMEN AND LEG. THE PATIENT REMOVED HER CLOTHES AND WASHED THE AREA 3 TIMES WITH SOAP AND WATER, THEN PUT ON HOSPITAL SCRUBS. PATIENT'S SKIN WAS INTACT AND NO IRRITATION WHEN SHE LEFT OUR INFUSION CENTER. THERE WAS A DELAY OF ABOUT AN HOUR SINCE THE REMAINING DRUG HAD TO BE STOPPED UNTIL THE SPILL IS CLEANED AND CONTACT THE PROVIDER. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: Chemical Exposure

  MAUDE report 24493849 ↗
• MalfunctionFeb 24, 2026Disconnection

  AN EVENT INVOLVING A SPINNING SPIROS CLOSED MALE LUER, RED CAP REPORTED THAT REGISTERED NURSE (RN) WENT INTO PATIENT'S ROOM TO CHECK ON PATIENT AND PATIENT NOTICED ONE OF HIS TUBING'S (THE HAZARDOUS SPIROS) CAME OFF AND BLOOD WAS BACKING UP INTO TRIFUSE. CHEMOTHERAPY WAS NOT INFUSING THROUGH THAT LINE AT THE TIME. THE RN STOPPED THE INFUSION RUNNING THROUGH THE SYRINGE LINE AND OBSERVED THAT THE SPIROS CAP ON THE PRIMARY TUBING HAD DETACHED, ALTHOUGH THE C-CAP REMAINED SECURE. THE PROVIDER AT THE BEDSIDE WAS NOTIFIED, AND THE RN CLEANED AND REPLACED THE TUBING. PRIOR TO INITIATING THE HAZARDOUS TUBING LINE, THE RN HAD VERIFIED THAT BOTH THE HAZARDOUS SPIROS CAP AND THE C-CAP WERE SECURE AND FUNCTIONING PROPERLY. THE EVENT RESULTED IN THE NEED FOR INCREASED PATIENT MONITORING. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427496 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO A SPINNING SPIROS CLOSED MALE LUER, RED CAP IN WHICH IT WAS REPORTED THAT THERE WAS A DEFECTIVE SPINNING SPIROS THAT LED TO A CHEMO SPILL. THE SPINNING SPIROS WAS BEING USED WITH THE BD TUBING. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM. ADDITIONALLY, THE CUSTOMER UPDATED, THAT IT WAS UNKNOWN IF THE PATIENT HAD ANY MTX GET ON HIS SKIN. NURSING CLEANED PATIENT UP PER POLICY, REMOVED GOWN, CHANGED LINEN, AND THERE WAS CHEMO ON THE FITTED SHEET BENEATH THE PATIENT. THERE WAS A DELAY AS A NEW PARTIAL DOSE HAD TO BE MADE UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373168 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED WITH REGARDS TO A SPINNING SPIROS CLOSED MALE LUER, RED CAP GENERATED A LEAK DURING PATIENT USE. IT WAS REPORTED THAT THERE MAY HAVE BEEN A DEFECT IN THE SPIROS TRANSFER DEVICE, CAUSING IT TO LEAK. ADDITIONALLY, IT WAS STATED THAT THEY MAY NOT HAVE CONNECTED THE NEEDLE TO THE SPIROS CONNECTOR COMPLETELY. THE EVENT OCCURRED DURING PATIENT USE FOR 2 MINUTES. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324152 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH AN ATTACHED USER FACILITY MANDATORY MEDWATCH REPORT NUMBER: (B)(4) WITH REGARDS TO A SPINNING SPIROS® CLOSED MALE LUER, RED CAP IN WHICH IT WAS REPORTED THAT THEY ATTACHED THE SPIROS EASILY TO THE B CHANNEL BUT WHEN THEY OPENED THE ROLLER CLAMP, CHEMO BEGAN TO SPEW OUT OF THE SPIROS ON THE SIDE AND LIQUID GOT ONTO THE TUBING, CHIP, AND PUMP. THEY QUICKLY HELD THE CHEMO BAG OVER THE CONNECTION TO BLOCK THE SPRAY AND CLOSED THE CLAMP, STOPPING THE FLOW. CHEMO RESIDUE WAS ON THE PUMP AND NO LIQUID CHEMO SPRAYED ONTO THE PATIENT OR ON THE MEDICAL PROFESSIONAL. IT CAUSES ONE HOUR DELAY FOR PATIENT THERAPY. A WHOLE NEW BAG AND SET UP WAS PROVIDED. THE PATIENT INVOLVED WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24297790 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082806. One submission often covers many models, so check the product and lot details in each record.

• Z-1723-2022 · Aug 1, 2022 · Open, Classified
  6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
• Z-1569-2021 · Mar 16, 2021 · Open, Classified
  REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration se
• Z-1568-2021 · Mar 16, 2021 · Open, Classified
  REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the
• Z-1567-2021 · Mar 16, 2021 · Open, Classified
  REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of
• Z-0702-2021 · Aug 31, 2020 · Open, Classified
  30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Sp