ICU Medical MC33717Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709064829), received between Feb 7, 2025 and Mar 26, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionMar 26, 2025Break; Fluid/Blood Leak; Material Separation; Break; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A 7.5" (19 CM) APPX 1.2 ML, BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 CLAMPS (2 WHITE, BLUE), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THEY HAVE HAD INCIDENT REPORTS OF BIFUSE BREAKING OFF FROM THE LUER CONNECTION. ALL THE BREAKS REPORTEDLY HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THE CUSTOMER STATED THAT THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, AND CHEMO SPILLS. THE CUSTOMER STATED THAT THERE WERE MANY INCIDENCES OF BROKEN EQUIPMENT BUT THEY ARE UNABLE TO GIVE ACCURATE INFORMATION ABOUT WHICH BROKEN EXTENSION TUBING (BI/TRI/QUAD FUSE) HAD HARM; THE CUSTOMER FURTHER STATED THAT MOST DID HAVE SOME HARM IN BLOOD LOSS BUT THE VOLUME OF BLOOD LOSS WAS NOT ABLE TO BE OBTAINED. THE CUSTOMER STATED THAT THE MAJORITY OF THE BLOOD LOSS WAS NOT SUBSTANTIAL ENOUGH TO REQUIRE BLOOD TRANSFUSION. THERE MAY HAVE BEEN SOME CHEMO EXPOSURE, BUT NONE REQUIRED EMERGENT CARE OR TREATMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699173 ↗
• MalfunctionFeb 7, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO 7.5" (19 CM) APPX 1.1 ML, BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS (2 WHITE, BLUE), LUER LOCK THAT EXPERIENCED BREAKAGE AND LEAKAGE. THE REPORTER STATED THAT "ALL THE BREAKS HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THEY THINK IT MAY BE A BONDING ISSUE. THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, CHEMO SPILLS, AND CAN POTENTIALLY CAUSE GREAT HARM FOR THE PATIENTS." "PATIENTS DID NOT SUFFER HARM AS THESE WERE FOUND QUICKLY, BUT THE PATIENT¿S DID LOSE BLOOD AND CHEMO WAS ALSO SPILLED".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21339717 ↗

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-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration 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-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-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-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-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-0233-2021 · Jul 6, 2020 · Terminated
  139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)1088
• Z-0186-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)
• Z-0191-2021 · Jul 6, 2020 · Terminated
  5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101
• Z-0236-2021 · Jul 6, 2020 · Terminated
  7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)1088770906
• Z-0194-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(0

…and 173 more.