ICU Medical MC33001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709037236), received between Apr 17, 2026 and May 12, 2026 — classified as 2 malfunctions.

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

188 other recalls cover devices cleared under the same FDA submission (K964435); 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.

• MalfunctionMay 12, 2026Disconnection

  AN EMAIL WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.69 ML EXT SET W/MICROCLAVE CLEAR, CLAMP, ROTATING LUER IN WHICH IT WAS REPORTED THAT THE PATIENT PERIPHERAL IV LINE CONNECTED TO ALARIS PUMP AND INFUSING MEDICATION DISONNECTER DURING USE AND LEAD TO BLOOD LOSS. THE PATIENT WAS WITNESSED BY WRITER RAISING HIS ARM, LINE WAS CLEAR OF OBSTACLES AND SECURED TO PATIENT, WITH NO TIGHTNESS IN INFUSION LINE. LUER LOCK CONNECTION AT THE TIP OF EXTENSION BECAME DISCONNECTED FROM THE REST OF THE LINE BUT REMAINED CONNECTED TO INFUSION LINE. THIS LEFT A PARTIAL EXTENSION TUBING OPEN TO THE ENVIRONMENT AND PATIENT BEGAN TO DRAIN BLOOD THROUGH PARTIAL EXTENSION CONNECTED TO IV LINE. WRITER APPLIED GREEN KELLY CLAMP OVER REMAINING PORTION OF EXTENSION TO STOP BLEEDING AND REPLACED THE EXTENSION WITH A NEW UNIT WITHOUT FURTHER COMPLICATION. THE PATIENT LOST LESS THAN 5CC OF BLOOD AS THIS EVENT WAS WITNESSED WITH PROMPT RESPONSE. THE PROCEDURE DONE WAS INTRAVENOUS ACCESS AND THERE WAS AN UNEXPECTED, PROLONGED CARE. THERE WAS A PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25153155 ↗
• MalfunctionApr 17, 2026Material Separation

  THE EVENT INVOLVED A SET EXTENSION 7IN W/MICROCLAVE CLEAR/CLAMP/ROTATING LUER CA/50 WHERE THE CUSTOMER REPORTED THAT DURING THE PATIENT¿S MEDICATION INFUSION, THE EXTENSION TUBING CAME APART FROM THE MICROCLAVE. T. THE PATIENT WAS ALREADY INFUSING, AND IT FELL APART DURING INFUSION THE PATIENT WAS NOT MOVING HIS INFUSION WHILE HE WAS HOOKED UP TO IT. THE REPORTER STATED THAT IN THIS INSTANCE, HE (THE PATIENT) HAD RECEIVED ALL OF THE MEDICATION AND ONLY MISSED THE NORMAL SALINE FLUSH TO CLEAR THE IV LINE. ONCE IT CAME APART, THE CUSTOMER STATED THAT THEY COULD NOT HOOK HIM BACK UP WITH ANOTHER EXTENSION AS THE LINE WAS NOW OPEN TO THE AIR LEAVING POTENTIAL FOR BACTERIA TO ENTER IN WHAT SHOULD BE A CLOSED SYSTEM. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916568 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0214-2021 · Jul 6, 2020 · Terminated
  99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515
• Z-0206-2021 · Jul 6, 2020 · Terminated
  60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit p
• Z-0189-2021 · Jul 6, 2020 · Terminated
  9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(0
• Z-0203-2021 · Jul 6, 2020 · Terminated
  8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30
• Z-0235-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50(10)4565730; (01)10887709067322(
• Z-0247-2021 · Jul 6, 2020 · Terminated
  7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravasc
• Z-0240-2021 · Jul 6, 2020 · Terminated
  11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI:(01)10887709088354(17)250101(30)50(10)4557643. The Intrava

…and 173 more.