ICU Medical CH4000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840619053222), received between Jun 13, 2019 and Sep 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  The event involved Diana Cassette assembly. It was reported that the liquid (5-FU) leaks from the system and crystallizes, despite several cassette replacements. Medication involved is 5-Fluorouracil (5-FU). The status of the product at the time of the event was unknown. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944816 ↗
• MalfunctionSep 15, 2026Break

  The event involved the product Diana Cassette assembly. It was reported that during installation of the set, the tip tilts and then breaks spontaneously, without any particular pressure being applied to it. Sample photo is provided showing the defective product that the tip tilts. There was no reported patient involvement and no reported patient harmed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769659 ↗
• MalfunctionMar 27, 2025Inaccurate Information; Inaccurate Information

  THE EVENT INVOLVED A DIANA CASSETTE WHERE THE CUSTOMER REPORTED THAT THE TECHNICAL OPERATOR WHO WAS SETTING UP THE CHEMOTHERAPIES NOTICED THAT THE QUANTITY TAKEN FROM DIANA (13 ML) DOES NOT CORRESPOND TO WHAT WAS SET ON THE DISPLAY (15 ML). WHEN INSPECTING THE SYRINGE OF THE CH4000 IN WHICH A DIFFERENT VOLUME OF DRUG WAS APPARENTLY WITHDRAWN, THE OPERATOR NOTICED THAT THE GRADUATED MARKS ARE NOT AT THE SAME LEVEL BETWEEN THIS CH4000 AND THOSE OF ANOTHER CH4000. THE CUSTOMER DID A COUNTER TEST THE FOLLOWING DAY USING PHYSIOLOGICAL SOLUTION AND ASPIRATING IT WITH ANOTHER SYRINGE AND THEY NOTICED THAT THE ISSUE WAS WITH THE CH4000 (ASPIRATES TWO ML MORE THAN THE LIQUID LEVEL ON THE SYRINGE MARK) AND NOT ON THE DIANA EQUIPMENT. THE CUSTOMER STATED THAT ONE DEFECTIVE DEVICE WAS FOUND. THE PREPARED CHEMOTHERAPY DRUGS WERE 5-FLUOROURACIL. THERE WAS NO PHYSICAL DEFECT ON THE CASSETTE. THE PROBLEM HAS NOT BEEN ENCOUNTERED WITH CERTAIN SPECIFIC DRUGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710844 ↗
• MalfunctionApr 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2022 AND INVOLVED A DIANA CASSETTE THAT THE CUSTOMER REPORTED AFTER PREPARATION OF INFUSERS THE OUTER SILICONE STRIP ON THE SPIROS BREAKS. THE EVENT OCCURRED DURING PREPARATION OF THE CYTOTOXIC MEDICATION CALLED FLUORO-URACIL USING THE DIANA PUMP. THE PRODUCT WAS IN USE FOR 30 MINUTES AND ONCE IT STARTED TO LEAK, THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT HARM, NO DELAY IN CRITICAL THERAPY. HOWEVER, THERE WAS UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE HEALTHCARE PROVIDER THAT WAS WEARING PPE. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS AND NO MEDICAL/ SURGICAL INTERVENTION REQUIRED. THIS CAPTURES THE SECOND OF FIVE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176657 ↗
• MalfunctionApr 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2022 AND INVOLVED A DIANA CASSETTE THAT THE CUSTOMER REPORTED AFTER PREPARATION OF INFUSERS THE OUTER SILICONE STRIP ON THE SPIROS BREAKS. THE EVENT OCCURRED DURING PREPARATION OF THE CYTOTOXIC MEDICATION CALLED FLUORO-URACIL USING THE DIANA PUMP. THE PRODUCT WAS IN USE FOR 30 MINUTES AND ONCE IT STARTED TO LEAK, THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT HARM, NO DELAY IN CRITICAL THERAPY. HOWEVER, THERE WAS UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE HEALTHCARE PROVIDER THAT WAS WEARING PPE. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS AND NO MEDICAL/ SURGICAL INTERVENTION REQUIRED. THIS CAPTURES THE FIFTH OF FIVE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176631 ↗
• MalfunctionApr 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2022 AND INVOLVED A DIANA CASSETTE THAT THE CUSTOMER REPORTED AFTER PREPARATION OF INFUSERS THE OUTER SILICONE STRIP ON THE SPIROS BREAKS. THE EVENT OCCURRED DURING PREPARATION OF THE CYTOTOXIC MEDICATION CALLED FLUORO-URACIL USING THE DIANA PUMP. THE PRODUCT WAS IN USE FOR 30 MINUTES AND ONCE IT STARTED TO LEAK, THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT HARM, NO DELAY IN CRITICAL THERAPY. HOWEVER, THERE WAS UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE HEALTHCARE PROVIDER THAT WAS WEARING PPE. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS AND NO MEDICAL/ SURGICAL INTERVENTION REQUIRED. THIS CAPTURES THE THIRD OF FIVE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176582 ↗
• MalfunctionApr 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2022 AND INVOLVED A DIANA CASSETTE THAT THE CUSTOMER REPORTED AFTER PREPARATION OF INFUSERS THE OUTER SILICONE STRIP ON THE SPIROS BREAKS. THE EVENT OCCURRED DURING PREPARATION OF THE CYTOTOXIC MEDICATION CALLED FLUORO-URACIL USING THE DIANA PUMP. THE PRODUCT WAS IN USE FOR 30 MINUTES AND ONCE IT STARTED TO LEAK, THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT HARM, NO DELAY IN CRITICAL THERAPY. HOWEVER, THERE WAS UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE HEALTHCARE PROVIDER THAT WAS WEARING PPE. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS AND NO MEDICAL/ SURGICAL INTERVENTION REQUIRED. THIS CAPTURES THE FOURTH OF FIVE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176560 ↗
• MalfunctionApr 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2022 AND INVOLVED A DIANA CASSETTE THAT THE CUSTOMER REPORTED AFTER PREPARATION OF INFUSERS THE OUTER SILICONE STRIP ON THE SPIROS BREAKS. THE EVENT OCCURRED DURING PREPARATION OF THE CYTOTOXIC MEDICATION CALLED FLUORO-URACIL USING THE DIANA PUMP. THE PRODUCT WAS IN USE FOR 30 MINUTES AND ONCE IT STARTED TO LEAK, THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT HARM, NO DELAY IN CRITICAL THERAPY. HOWEVER, THERE WAS UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE HEALTHCARE PROVIDER THAT WAS WEARING PPE. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS AND NO MEDICAL/ SURGICAL INTERVENTION REQUIRED. THIS CAPTURES THE FIRST OF FIVE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176278 ↗
• MalfunctionJun 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DIANA CASSETTE EXPERIENCED A LEAK OF FLUOROURACIL. THERE WAS NO INFORMATION ABOUT PATIENT INVOLVEMENT, ADVERSE EVEN OR MEDICAL INTERVENTION. THE EVENT OCCURRED ON AN UNKNOWN DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697842 ↗
• MalfunctionJun 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DIANA CASSETTE EXPERIENCED A LEAK OF FLUOROURACIL. THERE WAS NO INFORMATION ABOUT PATIENT INVOLVEMENT, ADVERSE EVEN OR MEDICAL INTERVENTION. THE EVENT OCCURRED ON AN UNKNOWN DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697829 ↗
• MalfunctionJun 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DIANA CASSETTE EXPERIENCED A LEAK OF FLUOROURACIL. THERE WAS NO INFORMATION ABOUT PATIENT INVOLVEMENT, ADVERSE EVENT OR MEDICAL INTERVENTION. THE EVENT OCCURRED ON AN UNKNOWN DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697816 ↗

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-3158-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-3160-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• 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-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-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-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
• 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