ICU Medical MC330583Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887709095861), received between May 28, 2025 and Jun 25, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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.

• MalfunctionJun 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 102" (259 CM) APPX 5.0 ML, TRANSFER SET W/MICROCLAVE¿ CLEAR, DUAL CHECK VALVE, SMALLBORE TRIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 0.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE A LEAK OF TPN (TOTAL PARENTERAL NUTRITION) FROM THE FILTER WAS REPORTED. THIS IS A NEAR MISS LEAK OF TPN TUBING CONTRIBUTES TO RISK OF INFECTION AND HYPOGLYCEMIA. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM, AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332818 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT INVOLVED A 102" (259 CM) APPX 5.0 ML, TRANSFER SET W/MICROCLAVE¿ CLEAR, DUAL CHECK VALVE, SMALLBORE TRIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 0.2 MICRON FILTER, CLAMP, ROTATING LUER. THE REPORTER STATED THAT THE PRODUCT IS LEAKING AT THE FILTER DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE ADVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193603 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT INVOLVED A 102" (259 CM) APPX 5.0 ML, TRANSFER SET W/MICROCLAVE¿ CLEAR, DUAL CHECK VALVE, SMALLBORE TRIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 0.2 MICRON FILTER, CLAMP, ROTATING LUER. THE REPORTER STATED THAT THE PRODUCT WAS LEAKING AN UNSPECIFIED FLUID AT THE FILTER DURING INFUSION. THERE WAS NO REPORTED ADVERSE ADVENT OR HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193473 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING THE 102" (259 CM) APPX 5.0 ML, TRANSFER SET W/MICROCLAVE¿ CLEAR, DUAL CHECK VALVE, SMALLBORE TRIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 0.2 MICRON FILTER, CLAMP, ROTATING LUER THAT EXPERIENCED LEAKAGE. IT WAS REPORTED THAT THE PRODUCT WAS LEAKING ON TWO OCCASIONS. A SAMPLE PHOTO WAS PROVIDED SHOWING THE AFFECTED PRODUCT. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102453 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 102" (259 CM) APPX 5.0 ML, TRANSFER SET W/MICROCLAVE¿ CLEAR, DUAL CHECK VALVE, SMALLBORE TRIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 0.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THE PRODUCT WAS LEAKING TOTAL PARENTERAL NUTRITION (TPN). THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096909 ↗

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-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-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-0224-2021 · Jul 6, 2020 · Terminated
  3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50
• Z-0200-2021 · Jul 6, 2020 · Terminated
  12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case. UDI: (01)10887709070100(17)250101(30)50(10)45727
• Z-0218-2021 · Jul 6, 2020 · Terminated
  126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01
• Z-0210-2021 · Jul 6, 2020 · Terminated
  13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)108
• Z-0215-2021 · Jul 6, 2020 · Terminated
  29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case. UDI:(01)10840619082533(17)250101(30)50(10)4605138. The Intravascular Admi
• Z-0211-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.50 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)
• Z-0216-2021 · Jul 6, 2020 · Terminated
  54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, n

…and 173 more.