ICU Medical, Inc. MC330523Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00887709092020), received between Nov 13, 2023 and Aug 31, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50528569 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209847 ↗
• MalfunctionMar 9, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE CLEAR/PUR YELLOW TRIFUSE EXT SET W/2 MICROCLAVE® CLEAR (YELLOW, GREEN RINGS), 2-0.2 MICRON FILTERS, ROTATING LUER AND IT WAS REPORTED THAT 0.2-MICRON FILTER ON TRIFUSE EXTENSION SET FOUND LEAKING AROUND THE 48-HOUR MARK. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542626 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE CLEAR/PUR YELLOW TRIFUSE EXT SET W/2 MICROCLAVE® CLEAR (YELLOW, GREEN RINGS), 2-0.2 MICRON FILTERS, ROTATING LUER GENERATED A LEAK DURING PATIENT USE. THE REPORT STATED, "TRIFUSE EXTENSION SET WAS LEAKING AT THE 0.2 MICRON FILTER ON THE GREEN RING LUMEN." A SAMPLE IS AVAILABLE FOR INVESTIGATION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562440 ↗
• MalfunctionApr 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE CLEAR/PUR YELLOW TRIFUSE EXT SET W/2 MICROCLAVE® CLEAR (YELLOW, GREEN RINGS), 2-0.2 MICRON FILTERS, ROTATING LUER WHERE IT WAS REPORTED THAT THE GREEN FILTER ON THE TRIFUSE SET WAS LEAKING. THE LEVEL OF HARM WAS MINIMAL AND PATIENT'S IMPACT TO THE INCIDENT WAS RISK OF INFECTION. THERE WAS NO SERIOUS HARM REPORTED. THERE WAS UNEXPECTED OR PROLONGED CARE. THUS, THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21779236 ↗
• MalfunctionNov 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE CLEAR/PUR YELLOW TRIFUSE EXT SET W/2 MICROCLAVE® CLEAR (YELLOW, GREEN RINGS), 2-0.2 MICRON FILTERS, ROTATING LUER WHERE IT WAS REPORTED GREEN FILTER WAS LEAKING DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT/SERIOUS HARM REPORTED. THIS REPORT CAPTURES 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20813870 ↗
• MalfunctionAug 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 127" (323 CM) APPX 9.7 ML TRANSFER SET W/CLAVE¿ CLEAR, DUAL CHECK VALVE, SMALLBORE TRIFUSE EXT SET W/1 PUR YELLOW, 2 CLAVE¿ CLEAR (YELLOW, GREEN RINGS), 2-0.2 MICRON FILTERS, SPIN LUER WHERE IT WAS REPORTED THAT THE TRIFUSE EXTENSION SET 0.2-MICRON FILTER WAS LEAKING AT THE GREEN RING LUMEN. THE EVENT OCCURRED DURING INFUSION OF PARENTERAL NUTRITION X 48 HOURS. LINE WAS CHANGED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980649 ↗
• MalfunctionJun 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE CLEAR/PUR YELLOW TRIFUSE EXT SET W/2 MICROCLAVE® CLEAR (YELLOW, GREEN RINGS), 2-0.2 MICRON FILTERS, ROTATING LUER GENERATED A LEAK DURING TESTING TO THE RETURNED DEVICE. AS PER THE INITIAL REPORT THE TRIFUSE EXTENSION SET WAS NOTED TO HAVE MOISTURE/STICKY FLUIDS ON THE GREEN RING LUMEN 0.2 MICRON FILTER. LUMEN WAS INFUSING AMINO ACIDS/DEXTROSE SOLUTION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613625 ↗
• MalfunctionJun 20, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE CLEAR/PUR YELLOW TRIFUSE EXT SET W/2 MICROCLAVE® CLEAR (YELLOW, GREEN RINGS), 2-0.2 MICRON FILTERS, ROTATING LUER. THE DEVICE'S GREEN FILTER WAS REPORTEDLY CRACKED AND LEAKING; IT NEEDED TO BE REPLACED WITH ANOTHER. THERE WAS NO APPARENT HARM THAT REACHED A PATIENT/PERSON, AND WAS REPORTED AS AN INCONVENIENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19577159 ↗
• MalfunctionMay 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE CLEAR/PUR YELLOW TRIFUSE EXT SET W/2 MICROCLAVE® CLEAR (YELLOW, GREEN RINGS), 2-0.2 MICRON FILTERS, ROTATING LUER WHERE IT WAS REPORTED STAFF WENT TO CHECK INFUSION LINES AND NOTICED THE FILTER OF INTRAVENOUS LINE WAS STICKY. THEY WIPED AREA WITH ALCOHOL SWAB AND WAITED 5 MINUTES, WHEN THE REPORTER CAME BACK THE GREEN FILTER WAS WET AND DRIPPING. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274765 ↗
• MalfunctionNov 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT INVOLVED A 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE CLEAR/PUR YELLOW TRIFUSE EXT SET W/2 MICROCLAVE® CLEAR (YELLOW, GREEN RINGS), 2-0.2 MICRON FILTERS, ROTATING LUER. IT WAS REPORTED THAT THE PATIENT'S FLUID LINES (DOWN TO CLAVE) WERE CHANGED, AND DROPS WERE FLOWING THROUGH THE TIP OF LINE. THE PUMP WAS FUNCTIONING WELL. THE FLUID LINE WAS CONNECTED TO THE PATIENT (A BABY), AND A SLIGHT AMOUNT OF BLOOD BACKED UP IN THE PICC (PERIPHERALLY INSERTED CATHETER) DUE TO A LOSS OF PRESSURE WHILE CLEANSING THE LINE AND WHILE WAITING FOR RECONNECTION. THE LINES WERE CONNECTED, AND THEN THE RN (REGISTERED NURSE) ASSISTED WITH HOLDING FOR X-RAY AND BLOOD WAS STILL BACKING UP IN PICC LINE THAT WAS CLOSEST TO BABY. THE TRANSPORT NURSE WAS REQUESTED TO ASSESS THE LINE, AND WAS THEN ALSO UNABLE TO FLUSH. PICC LINE REMOVAL/REINSERTION WAS REQUIRED. THERE WAS FLUID (TPN) PRESENT ON THE FLOOR AFTER THE COMPLAINT/ISSUE WAS DISCOVERED; HOWEVER, A CRACK OR LEAK IN THE LINES WAS NOT IDENTIFIED. THE PICC ASSESSMENT WAS GOOD THROUGHOUT THE SHIFT. THE REGISTERED NURSE THREW AWAY THE OLD LINES. THE BABY'S BLOOD GLUCOSE REMAINED STABLE THROUGHOUT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18126962 ↗

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-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-0187-2021 · Jul 6, 2020 · Terminated
  7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108877090510
• 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-0217-2021 · Jul 6, 2020 · Terminated
  Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709084435(17)250101(30)50(10)
• 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-0223-2021 · Jul 6, 2020 · Terminated
  26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The I
• 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-0184-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI: (01)10887709051031(

…and 173 more.