ICU Medical MC33257Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709037557), received between Feb 5, 2026 and Apr 22, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Break; Difficult to Open or Close

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CLINICIAN WOUND WAS CLEANED WITH SOAP AND WATER AND EMPLOYEE FOLLOWED UP WITH EMPLOYEE HEALTH FOR BLOOD DRAW FOR NEEDLESTICK BATTERY AND NO FURTHER TREATMENT NEEDED BEYOND THAT. THERE WAS A PATIENT INVOLVEMENT WITH NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957259 ↗
• MalfunctionFeb 5, 2026Crack; Fluid/Blood Leak

  THE CUSTOMER-REPORTED EVENT INVOLVED A 7" SMALLBORE PRESSURE INFUSION (400PSIG) BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUER. THE IV LOCKS WERE CRACKED VERTICALLY IN THREE PLACES OF THE DEVICE. A CRACK WAS IDENTIFIED HORIZONTALLY ACROSS THE BASE WHILE ATTACHING TO PATIENT, LEADING TO BLOOD LEAKAGE. THE DEVICE WAS CLEANED, AND THEN THEY NOTICED THE CRACKS IN THE SALINE LOCK AND THE BLOOD LEAKAGE CONTINUED. THE INTRAVENOUS (IV) LOCK WAS REPLACED IMMEDIATELY FOR THE PATIENT. THERE WAS NO REPORTED HUMAN HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24271042 ↗

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-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-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-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