ICU Medical MC330310Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709083189), received between Jan 10, 2025 and Jan 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Leak/Splash; Leak/Splash

  THE COMPLAINT/EVENT INVOLVED A 14" (36 CM) EXT SET W/1.2 MICRON FILTER, MICROCLAVE® CLEAR, CLAMP, ROTATING LUER. A LEAK WAS REPORTED FROM THE PORT ON THE LIPID TUBING DIRECTLY BELOW LIGHT BLUE ALCOHOL CAP. THE INFUSION LINE WAS STOPPED AND THE TUBING WAS DISCONNECTED. UPON DISCONNECTING THE INFUSION LINE AT THE BLUE CAP SITE PRIOR TO FLUSHING, THE NURSE NOTICED THE HUB ON THE CAP THAT CONNECTED TO THE PATIENT (NOT ON TUBING, ON DARK BLUE BIFURCATED EXTENSION) DID NOT LAY FLUSH. AS SUCH, IF ONE WERE TRYING TO SCRUB THE HUB THERE WAS AN INDENT AND IT WAS NOT FLAT. THERE WAS NO PATIENT HARM, BUT THE PATIENT DID NOT RECEIVE THE FULL DOSE OF PRESCRIBED LIPIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21145918 ↗
• MalfunctionJan 13, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE COMPLAINT/EVENT INVOLVED A 14" (36 CM) EXT SET W/1.2 MICRON FILTER, MICROCLAVE® CLEAR, CLAMP, ROTATING LUER. THE REPORTER STATED THAT SHE CLAMPED THE TOTAL PARENTERAL NUTRITION (TPN) AT THE QUADFUSE AND ATTEMPTED TO BEGIN INFUSING THE LIPIDS ON THE PUMP. THE LIPIDS NEVER INFUSED THROUGH THE CAP INTO THE QUADFUSE. UPON UNCLAMPING THE TPN, IT IMMEDIATELY BACK-FLOWED BACK UP INTO THE LIPID TUBING. THERE WAS NO PATIENT HARM, BUT THE PATIENT DID NOT RECEIVE THE FULL DOSES OF PRESCRIBED LIPIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21145830 ↗
• MalfunctionJan 10, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A 14" (36 CM) EXT SET W/1.2 MICRON FILTER, MICROCLAVE® CLEAR, CLAMP, ROTATING LUER WHERE A REPORT STATED THAT PARTS OF THE LIPID LINE TUBING BREAKING OR LEAKING. THE RN FOUND LIPID TUBING AT SITE NEAR FILTER DISCONNECTED AND BROKEN OFF. LIPIDS WERE CONTINUING TO RUN BUT NOT GOING TO PATIENT. WHEN FOUND, LIPIDS STOPPED, AND THE REST OF THE LINE WAS DISCONNECTED FROM THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM, BUT ALL PATIENTS DID NOT RECEIVE THEIR FULL DOSES OF PRESCRIBED LIPIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21128693 ↗

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-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-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-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-0232-2021 · Jul 6, 2020 · Terminated
  58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460
• Z-0190-2021 · Jul 6, 2020 · Terminated
  9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053004(17)250101(30)50
• 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
• 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-0238-2021 · Jul 6, 2020 · Terminated
  11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)1

…and 173 more.