ICU Medical MC330472Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887709095854), received between Oct 8, 2024 and Nov 24, 2025 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 60" (152 CM) PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, 1.2 MICRON FILTER, CLAMP, LUER LOCK AND IT WAS REPORTED THAT LIPID TUBING WAS FOUND TO BE LEAKING SHORTLY AFTER HANGING TUBING. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640817 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 60" (152 CM) APPX 1.4 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, 1.2 MICRON FILTER, CLAMP, LUER LOCK. IT WAS REPORTED THAT THEY HAVE A PATIENT THAT IS RUNNING PARENTERAL NUTRITION UTILIZING OUR INFUSION PRODUCTS. THEY ARE EXPERIENCING AN ALLERGIC REACTION EACH DAY SHORTLY AFTER STARTING THE INFUSION, WHICH RESOLVES WITH TREATMENT AND DOES NOT RETURN DESPITE CONTINUING THIS INFUSION. NO NOTED PRODUCT DEFECTS UPON OPENING/UNOPENED. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23613389 ↗
• MalfunctionOct 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A 0" (152 CM) PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, 1.2 MICRON FILTER, CLAMP, LUER LOCK WHERE IT WAS REPORTED THAT SMALLBORE LIPID FILTERED TUBING WAS LEAKING AND ALLOWED BLOOD TO BACK UP INTO THE TUBING. REPORT STATED THE PATIENT WAS SLIGHTLY INJURED, NOT FURTHER DETAIL REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393064 ↗
• MalfunctionJul 24, 2025No Flow; No Flow

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A 60" (152 CM) PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, 1.2 MICRON FILTER, CLAMP, LUER LOCK BECAME OCCLUDED DURING PATIENT USE. IT WAS REPORTED "OCCLUDED LIPID LINE". THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587187 ↗
• MalfunctionFeb 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE DEVICE LEAKED AT THE FILTER DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, A DELAY IN THERAPY AND THE PATIENT REQUIRED A BLOOD TRANSFUSION. ADDITIONAL INFORMATION IS BEING REQUESTED. THE EXACT DATE OF THE EVENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21368246 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON UNSPECIFIED DATES BETWEEN 02-DEC-2024 AND 13-JAN-2025 AND INVOLVED A 60" (152 CM) APPX 1.4 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, 1.2 MICRON FILTER, CLAMP, LUER LOCK. THE CUSTOMER REPORTED THAT THE DEVICE WAS LEAKING LIPIDS. THERE WAS PATIENT INVOLVEMENT, A DELAY IN THERAPY DUE TO CHANGING OR HAVING TO REMOVE THE DRIP ALTOGETHER BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360741 ↗
• MalfunctionOct 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 60" (152 CM) APPX 1.4 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, 1.2 MICRON FILTER, CLAMP, LUER LOCK. THE REPORTER STATED THAT THEY HAD A LEAKING FILTER (UNSPECIFIED INFUSATE). THERE WAS NO HUMAN HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20400296 ↗

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-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-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
• Z-0234-2021 · Jul 6, 2020 · Terminated
  47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01
• Z-0256-2021 · Jul 6, 2020 · Terminated
  149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;
• Z-0253-2021 · Jul 6, 2020 · Terminated
  60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. The Intravascular
• Z-0221-2021 · Jul 6, 2020 · Terminated
  83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. UDI:(01)10887709089508(17)250101(30)25(10)45
• 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

…and 173 more.