ICU Medical MC9004Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709039315), received between Aug 15, 2023 and Apr 29, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

8 other recalls cover devices cleared under the same FDA submission (K100576); 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.

• MalfunctionApr 29, 2026Fluid/Blood Leak

  ON AN UNSPECIFIED DATE, BLOOD REPORTED LEAKED OUT OF THE END OF THE J-LOOP WITH THE FOLLOWING MEDICAL DEVICE: 9" (23 CM) APPX 0.69 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, CLAVE® CLEAR, CLAMP, ROTATING LUER. THE NURSE WAS USING A SYRINGE TO FLUSH THE PATIENT'S PERIPHERAL IV. THE J-LOOP SET WAS ATTACHED TO THE INSYTE WITH AN ENDCAP. THE ENDCAP STAYED CONNECTED TO THE SYRINGE THAT WAS USED TO FLUSH THE SITE AND THIS LED TO UNEXPECTED BLOOD LEAKING FROM THE END OF THE J-LOOP WHERE IS SUPPOSED TO BE AND INTACT AND SECURE LEURLOCK CAP. AFTER CLAMPING THE J-LOOP, THE PERIPHERAL IV (PIV) REMOVED INTACT. THERE WAS NO PATIENT HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25035820 ↗
• MalfunctionMar 13, 2025Disconnection; Disconnection

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 9" (23 CM) APPX 0.69 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, CLAVE® CLEAR, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED A DISCONNECTION ISSUE OF THE MALE LUER. THERE WAS NO REPORT OF ANY HUMAN HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600554 ↗
• MalfunctionNov 14, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A 9" (23 CM) APPX 0.77 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE¿ CLEAR, CLAVE¿ CLEAR, CLAMP, ROTATING LUER WHERE WE RECEIVED A MEDWATCH VOLUNTARY WITH MDR REPORT MW5159531 WHERE THE REPORT STATED THAT A PATIENT WAS BROUGHT IN FOR ANGIO, FLUSHED IV- STARTED ANGIO, NO CONTRAST SEEN. THEY WENT TO THE CHECK THE PATIENT, HUB OF NEW IV TUBING POPPOED OFF- CONTRAST SPRAYED ALL OVER THE PATIENT, CT TABLE AND FLOOR. THEY HAD TO REPEAT TRIGGER, THIS IS THE SECOND TIME THE USER HAD EXPERIENCED THE PROBLEM. THERE WAS A 62-YEAR-OLD BLACK OR AFRICAN AMERICAN FEMALE INVOLVED, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20691598 ↗
• MalfunctionSep 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 9" (23 CM) APPX 0.77 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE¿ CLEAR, CLAVE¿ CLEAR, CLAMP, ROTATING LUER GENERATED A LEAK DURING PATIENT USE. THE REPORT STATED THAT THEY ARE CLAIMING THAT WHEN DRAWING BLOOD, THEY NOTICED THAT BLOOD SQUIRTS OUT FROM THE PROXIMAL REMOVABLE MICROCLAVE WHEN DISCONNECTED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20177473 ↗
• MalfunctionSep 3, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 9" (23 CM) APPX 0.77 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE¿ CLEAR, CLAVE¿ CLEAR, CLAMP, ROTATING LUER WHERE IT WAS REPORTED WHEN DRAWING BLOOD, BLOOD SQUIRTS OUT FROM THE PROXIMAL REMOVABLE MICROCLAVE WHEN DISCONNECTED. IT WAS ALSO STATED THAT THE REMOVABLE MICROCLAVE IS TOO LOOSE IN THE PACKAGE. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125554 ↗
• MalfunctionAug 15, 2023Disconnection; Disconnection

  IT WAS REPORTED, ON AN UNKNOWN DATE, A 9" (23 CM) APPX 0.77 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE¿ CLEAR, CLAVE¿ CLEAR, CLAMP, ROTATING LUER WAS FOUND DEFECTIVE IN THE EMERGENCE DEPARTMENT WITH THE INNER PART OF THE ADAPTER COMING OUT OF THE HOUSING DURING USE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548669 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100576. 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-1720-2022 · Aug 1, 2022 · Open, Classified
  8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
• Z-0197-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multi
• Z-0204-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per
• Z-0193-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouche
• Z-0201-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case.
• Z-0192-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 mul
• Z-1916-2020 · Oct 4, 2019 · Terminated
  REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889