ICU Medical MC33450Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709038905), received between Apr 15, 2019 and Apr 17, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONCE THE INTRAVENOUS TREATMENT WAS STARTED ON THE PATIENT, BLOOD WAS DRAWN FROM THE HUB, THEN STARTED FLOWING OUT OF THE DEVICE NONSTOP. THE DEVICE INVOLVED IN THE EVENT WAS REPORTED TO BE REPLACED WITHOUT FURTHER INCIDENT. THERE WAS PATIENT INVOLVEMENT HOWEVER THERE WAS NO ADVERSE EVENT, HARM, OR DELAY IN CRITICAL THERAPY REPORTED. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 8524543 ↗
• MalfunctionApr 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A CUSTOMER REPORT OF PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR THAT HAD BLOOD FLOWING OUT OF IT. IT WAS REPORTED AN INTRAVENOUS (IV) LINE WAS STARTED ON A PATIENT, BLOOD WAS DRAWN FROM THE IV HUB USING A COVIDIEN VACUTAINER, THEN THE EXTENSION SET WAS CONNECTED TO THE IV HUB AND FLUIDS STARTED. THE DEVICE WAS REPLACED. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT OR DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522982 ↗
• MalfunctionApr 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A CUSTOMER REPORT OF PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR THAT HAD BLOOD FLOWING OUT OF IT. IT WAS REPORTED AN INTRAVENOUS (IV) LINE WAS STARTED ON A PATIENT, BLOOD WAS DRAWN FROM THE IV HUB USING A COVIDIEN VACUTAINER, THEN THE EXTENSION SET WAS CONNECTED TO THE IV HUB AND FLUIDS STARTED. THE PATIENT WAS LATER DISCONNECTED TO USE THE BATHROOM, AND THE DEVICE WAS COVERED WITH A GREEN CAP. IT WAS REPORTED THAT BLOOD STARTED FLOWING OUT OF THE EXTENSION SET NONSTOP. THE DEVICE WAS REPLACED. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT OR DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515749 ↗

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-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-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-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-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-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