ICU Medical MC33688Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887709064379), received between Feb 19, 2025 and Nov 21, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  THE EVENT INVOLVED A 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3 WHITE, RED), ROTATING LUER. IT WAS REPORTED THAT BLOOD WAS LEAKING FROM IV QUADFUSE. THE WRITER NOTED THE BLOOD AND STOPPED THE LEAKING BY CLAMPING THE LEAKING QUADFUSE AND CHANGING IT AFTERWARDS. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM WAS NOT REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23614772 ↗
• MalfunctionMay 7, 2025Crack; Crack

  THE EVENT INVOLVED A 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3 WHITE, RED), ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE EXTENSION PORT TO WHICH PATIENT'S DINUTUXIMAB WAS CONNECTED, BOWED AND CRACKED. 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 21980516 ↗
• MalfunctionMar 26, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3 WHITE, RED), ROTATING LUER WHERE THE CUSTOMER REPORTED THAT DURING BED BATH, CLAVE OF ONE OF PATIENT'S MEDICATIONS FOUND TO BE BROKEN AND DRAINING INTO THE BED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698175 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3 WHITE, RED), ROTATING LUER WHERE IT WAS REPORTED THAT IT APPEARED THAT QUAD FUSE WAS BACKED UP AND STARTED LEAKING LIPIDS. THE EVENT OCCURRED DURING USE FOR PATIENT AT PEDIATRIC MEDICINE. THUS, THERE WAS PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414757 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3 WHITE, RED), ROTATING LUER WHERE THE REPORTER STATED THAT PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE NOTED TO BE LEAKING AT QUAD-FUSE SITE AT 03:00. THEN UPON INVESTIGATION IT WAS NOTED THAT THERE WAS BACKING UP AND LEAKING OF FLUIDS AT THE QUADFUSE. THE EVENT OCCURRED DURING IN USE FOR PATIENT AT PEDIATRIC MEDICINE. THUS, THERE WAS PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414627 ↗

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-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-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-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-0207-2021 · Jul 6, 2020 · Terminated
  13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)
• Z-0205-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080703(17)250101(30)5
• Z-0259-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)1
• 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-0209-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709090238(17)250101(30)50(10)45729
• Z-0183-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:(01)10887709051024(17)250101(30)50(10)
• Z-0244-2021 · Jul 6, 2020 · Terminated
  128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887

…and 173 more.