ICU Medical MC330027Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00887709076419), received between Aug 29, 2023 and Sep 21, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Air/Gas in Device

  The event involved a 7" (18 cm) Appx 0.52 ml, Smallbore Trifuse Ext Set w3 MicroClave Clear, 3 Clamps, Luer Lock. It was reported that during a lab blood draw from the patient's PICC (Peripherally Inserted Central Catheter), the syringe filled with air instead of blood while the nurse was drawing back waste. The nurse observed that air was entering the line from the hub of the trifuse. The trifuse was immediately clamped and removed. No air reached the patient. The patient remained stable with no changes in vital signs or neurologic function, and no harm was reported. No issues were noted while priming the trifuse.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839449 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak

  AN EVENT INVOLVING A 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAMPS, LUER LOCK REPORTED THAT THE PATIENT RECEIVING FLUIDS AND MEDS THROUGH A TRIFUSE TUBING ADAPTOR AND IT STARTED TO LEAK PROFUSELY. PATIENT WAS RECEIVING LACTATED RINGERS (LR) MAINTENANCE FLUIDS AND LACOSAMIDE FOR SEIZURES. SMALL AMOUNT OF FLUID/MEDICATION LOST DUE TO LEAKAGE AND VOLUME REPLACEMENT. POTENTIAL FOR A LOWER SEIZURE THRESHOLD DUE TO UNDERDOSE OF SCHEDULED SEIZURE MED BECAUSE OF LEAKAGE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412573 ↗
• MalfunctionFeb 10, 2026Break

  AN EMAIL WAS RECEIVED REGARDING SMALLBORE TRIFUSE EXT SET GENERATED A BREAK DURING PATIENT USE. IT WAS REPORTED THAT LIPIDS HAD BEEN STOPPED BUT LEFT IN LINE ON THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). RESTARTED LIPIDS AT 1300, AND WHEN CHANGED OUT THE TUBING, THE CLAVE ON THE TRIFUSE BROKE OFF. THE LINE WITH THE LIPIDS HAD BEEN CLAMPED, SO NO AIR WENT INTO THE LINE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303753 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAMPS, LUER LOCK . THE REPORTER STATED THAT IN THE LAST WEEK, THEY HAD AN UPTICK OF INCIDENTS IN RELATION TO THE USE OF THE BI FUSE AND TRI FUSE THAT THEY USE FROM ICU MEDICAL. THE PATIENT NEEDED TO HAVE TWO CONTINUOUS CHEMO RUNNING. RN PLACED BI FUSE ON PT LINE AND ATTACHED CHEMO WITH CTSD. RN NOTED THAT WHEN BIFUSE ATTACHED TO CSTD IT WAS ABLE TO BE PULLED OFF OF THE CSTD WITH SMALL AMOUNT OF PULLING, DUE TO SMALLER COLLAR ON BIFUSE. TRIFUSE WAS THEN USED SINCE COLLAR IS LONGER AND ABLE TO BE FULLY TWISTED ONTO CSTD. PATIENT TUBING THEN GOT STUCK IN THE RECLINER AS MOM (MEDICAL MOM) WAS PICKING PATIENT UP. LINE SNAPPED ON THE TRIFUSE IN BETWEEN SKINNY PORTION OF LINE AND FUSE. AGAIN, DROPS OF CHEMO NOTED TO BE ON FLOOR BUT MOSTLY BLOOD DUE TO PATIENT LINE BEING OPEN. THE PRODUCT HAVE COME IN CONTACT WITH THE PATIENT AND/OR STAFF MEMBER, YET THE MEDICATION BEING ADMINISTERED, DID NOT GET ON PATIENT OR STAFF SKIN OR CLOTHING. THE CHEMO SPILL CLEANED UP PER FACILITY PROTOCOL. THUS, NO STAFF OR PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097352 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAMPS, LUER LOCK THAT EXPERIENCED SEPARATION AND LEAKAGE. THE REPORTER STATED THAT IN THE LAST WEEK, THEY HAD AN UPTICK OF INCIDENTS IN RELATION TO THE USE OF THE BI FUSE AND TRI FUSE THAT THEY USE FROM ICU MEDICAL. MOM (MEDICAL MOM) CALLED OUT TO REPORT TUBING HAD BROKEN. CVL WAS INTACT, THOUGH, THROUGH TO WHERE THE TRIFUSE CONNECTED. RN ASSESSED, AND TUBING WAS DISCONNECTED AS IT CAME OUT OF TRI-FUSE BOTTOM (TUBING HAD PULLED APART, NOT AT A LUER-LOCK, BUT WITHIN THE TUBING ITSELF). A STERILE CAP CHANGE WAS DONE, A TUBING CHANGE, AS WELL AS A PUMP CHANGE WERE DONE. THE PRODUCT HAVE COME IN CONTACT WITH THE PATIENT AND/OR STAFF MEMBER, YET THE MEDICATION BEING ADMINISTERED, DID NOT GET ON PATIENT OR STAFF SKIN OR CLOTHING. THE CHEMO SPILL CLEANED UP PER FACILITY PROTOCOL. THUS, THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO STAFF OR PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097118 ↗
• MalfunctionMay 21, 2025Disconnection; Disconnection

  THE COMPLAINT/EVENT INVOLVED OCCURRED ON AN UNSPECIFIED DATE IN APRIL 2025 AND INVOLVED A 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAMPS, LUER LOCK. THE REPORTER STATED THAT IN THE LAST WEEK, THEY HAD AN UPTICK OF INCIDENTS IN RELATION TO THE USE OF THE TRIFUSE DEVICE FROM ICU MEDICAL. FOR THIS SPECIFIC EVENT, THE NURSE WAS CALLED INTO THE ROOM DUE TO CARBOPLATIN CHEMO TUBING DISCONNECTING. CHEMO PIECES WERE DISCONNECTED FROM THE TRIFUSE. A MINIMAL AMOUNT OF CHEMO WAS LOST. IT WAS STATED THAT THE PATIENT'S MOM TRANSFERRED THE PATIENT FROM HOLDING HIM IN THE CHAIR TO THE CRIB AND THE TPN LINE GOT DISCONNECTED AT THE SITE WHERE IT CONNECTS TO THE T CONNECTOR. THIS RN NOTICED LINE WAS LAYING ON THE FLOOR- PLACED A BLUE CAP ON THE LINE AND NOTIFIED THE TEAM. CAT TEAM NURSE WAS ALSO IN THE ROOM FOR A DRESSING CHANGE WITH THE RN. THE MED TEAM ORDERED THE TPN TO HANG EARLIER TO MINIMIZE THE TIME OFF OF TPN AND TO KEEP PATIENT ON HOME SCHEDULE. THIS RN DISPOSED OF THE TPN BAG AND TUBING THAT FELL ONTO THE FLOOR. THE LOCATION WAS W12. THE PRODUCT COULD POTENTIALLY HAVE COME IN CONTACT WITH THE PATIENT AND/OR STAFF MEMBER, YET THE MEDICATION THAT WAS BEING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064113 ↗
• MalfunctionMay 8, 2025Crack; Disconnection; Crack; Disconnection

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAMPS, LUER LOCK WHERE THE CUSTOMER REPORTED THAT THE TRIFUSE BECAME DISCONNECTED FROM THE LIPID LINE AS THE CONNECTOR HAD BROKEN. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS USE ON A PATIENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988804 ↗
• MalfunctionJan 16, 2025Material Separation; Material Separation

  THE COMPLAINT/EVENT INVOLVED A 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAMPS, LUER LOCK. IT WAS REPORTED THAT THE LIPID LINE HAD SNAPPED INSIDE THE TRIFUSE AND POPPED OFF DURING A PATIENT'S INFUSION. THERE WAS NO HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170605 ↗
• MalfunctionJan 14, 2025Disconnection; Disconnection

  ADDITIONAL INFORMATION WAS RECEIVED VIA MEDSUN MEDWATCH MANDATORY AND VOLUNTARY REPORT WITH UF/IMPORTER REPORT # (B)(4) ON 15-JAN-2025. THE REPORT STATED: "UPON TRACING LINES, WE NOTICED THE LIPID TUBING WAS DISCONNECTED FROM THE TRIFUSE. WHEN INSPECTING FURTHER, THE PORT ON THE TRIFUSE WAS BROKEN IN AND LOCATED IN THE TRIFUSE. NEW LIPID TUBING WERE PRIMED WITH NEW LIPID SYRINGE AND NEW TRIFUSE WAS PRIMED/CHANGED OUT FOR PATIENT.¿ THE REPORT WAS COMPLETED BY MIKE LIGOCKI, A HEALTH PROFESSIONAL. THE CONTACT PERSON IS (B)(6) HOSPITAL. THE EVENT DATE IS DEC-2024, AND THE DATE REPORTED IS JAN-2025 AS INITIAL REPORT. THE EVENT OCCURRED AT THE HOSPITAL USER FACILITY. THE SUSPECTED MEDICAL DEVICE WAS A TRIFUSE WITH ITEM NUMBER MC330027 AND LOT NUMBER 14104635 WITH A COMMON DEVICE NAME STOPCOCK, I.V. SET WITH PROCODE FMG. EXPIRY DATE UNKNOWN. THIS A SINGLE-USE DEVICE AND WAS NOT REPROCESSED AND REUSED ON A PATIENT AND THIS DEVICE WAS NEVER SERVICED BY A THIRD-PARTY SERVICER. THE SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, A 1-MONTH-OLD FEMALE AND THE RACE IS WHITE. NO PATIENT HARM AND DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154175 ↗
• MalfunctionJan 8, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON VARIOUS DATES IN 2024 AND INVOLVED A 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAMPS, LUER LOCK. THE TRIFUSE REPORTEDLY DID NOT THREAD TIGHTLY AND PULLED RIGHT OFF WITH LITTLE EFFORT. MULTIPLE STAFF MEMBERS REPORTED THE SAME ISSUE TOTALING FIVE INCIDENTS APPROXIMATELY BETWEEN 25NOV2024 AND 13EC2024. THE REPORTED ISSUE WAS SUSPECT FOR A CHEMO SPILL, BUT THE DEVICE WAS DISCARDED WITH THE SPILL. THERE WAS NO REPORT OF ANY HUMAN HARM. THIS EMDR REPRESENTS FIVE OF THE SAME/SIMILAR OCCURRENCES WITH NO DIFFERING SPECIFIC DETAILS ACROSS THE INCIDENTS.

  Patient problems: Chemical Exposure

  MAUDE report 21107360 ↗
• MalfunctionNov 14, 2024Separation Problem; Separation Problem

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAMPS, LUER LOCK WHERE TT WAS REPORTED THAT THE DEVICE HAD A DRAWING LABS FROM A CENTRAL LINE USING TRIFUSE THEN AFTER DRAWING BACK MY WASTE AND CLAMPING THE TUBING, THE CLAVE DETACHED FROM THE TUBING OF THE TRIFUSE. THERE WAS A PATIENT INVOLVED BUT NO HARM ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684426 ↗
• MalfunctionNov 29, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAMPS, LUER LOCK. IT WAS STATED IN THE REPORT THAT THE TRIFURCATE HAD A MICRO-CLAVE THAT WAS CRACKED, IT CAUSED BLOOD TO FLOW BACK TO THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE AND FOR THE FATS TO LEAK OUT. WHEN IT WAS TIME FOR THE HEALTHCARE PROFESSIONAL TO DO THE ASSESSMENT, IT WAS NOTICED THAT THE BED WAS SOAKED. UPON TRACING BACK THE LINES, IT WAS DISCOVERED THAT THE MICROCLAVE HAD A CRACK IN IT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18228825 ↗
• MalfunctionAug 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAMPS, LUER LOCK. IT WAS STATED THAT THE FATHER CAME OUT SAYING THAT THE MOTHER HAD A WET SHIRT, AND ONE OF THE LINES WERE LEAKING. NURSING STAFF WENT IN TO EXAMINE CONNECTIONS AND CHECKED TO SEE IF THERE WAS A LEAK ANYWHERE. IT WAS TIME TO CHANGE THE TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS, SO NURSING STAFF DECIDED TO CHANGE ALL TUBING SETUP. AFTER SWITCHING WHOLE TUBING SET UP, NURSING STAFF EXAMINE THE LINES CLOSER. THE PARENTS MENTIONED THAT MAYBE IT WAS THE HUB ON THE TRIFURCATOR, SO NURSING STAFF STARTED THERE AND WAS ABLE TO FIND A SMALL HOLE WHERE LIQUID WAS LEAKING. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644955 ↗

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-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-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-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-0243-2021 · Jul 6, 2020 · Terminated
  78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)10887709121703(17)250201(30)50(10)4723226.
• 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-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-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
• Z-0208-2021 · Jul 6, 2020 · Terminated
  12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(3
• Z-0225-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088501(17)250201(30)25(10)4733705.
• Z-0245-2021 · Jul 6, 2020 · Terminated
  126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062365(17)250201(30)25(10)4630752. The Intrav

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