ICU Medical MC33687Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00887709064362), received between May 2, 2024 and Mar 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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.

• MalfunctionMar 30, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING TO A SMALLBORE TRIFUSE EXT SET, IN WHICH IT WAS STATED THAT WHEN IV DEXRAZOXANE WAS STARTED, THEY NOTICED LEAKING FROM ONE OF THE EXTENSION PIECES ON THE TRI-FUSE CONNECTOR AT THE MICRO-CLAVE PART. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735928 ↗
• MalfunctionJan 12, 2026Material Separation

  THE EVENT INVOLVED A 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE CLEAR, 2 CHECK VALVE, 3 CLAMPS (2 WHITE, RED), ROTATING LUER. IT WAS REPORTED THAT NEW LINES AND FLUIDS WERE STARTED AT 16:00, WHEN COMPLETING HOURLY (Q1H) PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) ASSESSMENT AT 17:00 THE TRIFUSE CAP WAS NOTED TO BE MISSING WITH CUROS CAP. LINE APPEARED TO BE SNAPPED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038394 ↗
• MalfunctionSep 3, 2025No Flow; No Flow

  EVENT OCCURRED REGARDING A 4" (10 CM) SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHECK VALVE, 3 CLAMPS (2 WHITE, RED), ROTATING LUER WHERE THEY STATED IN THE REPORT THAT "PATIENT SEEN AT 0600 FOR HOURLY CHECK, RIGHT SHOULDER AND BLANKET NOTED TO HAVE BLOOD ON IT. BLOOD BACKING UP INTO TRIFUSE EXTENSION AND BLOOD AROUND EXTENSION PIECES. EVERYTHING CONNECTED. EXTENSION TRIFUSE EXCHANGED AND INFUSING WELL WITHOUT ISSUES NOW." THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22951863 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  A COMPLAINT WAS RECEIVED REGARDING A 4" (10 CM) APPX 0.89 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHECK VALVE, 3 CLAMPS (2 WHITE, RED), ROTATING LUERTHAT EXPERIENCED LEAKAGE. IT WAS REPORTED THAT PATIENT WITH HISTORY OF SEIZURES AND REQUIRED SEDATION DUE TO DECOMPENSATION FROM DAY SHIFT PRIOR. WRITER FOUND A WET SPOT UNDER THE TRIFUSE RUNNING THE MIDAZOLAM (FOR SEIZURES AND SEDATION) AND THE HYDROMORPHONE (SEDATION). THE ACTUAL TRIFUSE LOOKED LIKE IT WAS DAMAGED DURING THE MANUFACTURING PROCESS AS THE CLAVE LOOKS CROOKED WHERE IT'S FUSED TO THE FILTER. THIS FUSE WAS RUNNING MIDAZ WHICH WAS INITIATED FOR SEIZURES AND THAT NIGHT THE PATIENT HAD NEW EYE DEVIATION FINDINGS (THOUGH NO TRUE SIGNS OF SEIZURES). DO NOT KNOW IF THIS IS CONNECTED TO THE MIDAZ FUSE LEAKING. THE DATE OF INCIDENT WAS ON (B)(6) 2025 AT 08:00:00 IN CCCU (CARDIAC CRITICAL CARE UNIT). THE DEFECTIVE ITEM WAS SAVED AND IS AVAILABLE FOR INVESTIGATION. PHOTOS OF THE ACTUAL DEFECTIVE ITEM WERE PROVIDED. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS USED ON A PATIENT. THE SAMPLE DOES NOT CONTAIN ANY HAZARDOUS MATERIALS. THERE WAS NO PATIENT HARM AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22101652 ↗
• MalfunctionMay 22, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" (10 CM) SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHECK VALVE, 3 CLAMPS (2 WHITE, RED), ROTATING LUER WHERE IT WAS REPORTED WHEN PATIENT WAS BEING WEIGHED, MOM PICKED UP PATIENT, AND ONE OF THE LINES BROKE. THIS RESULTED IN THE CLOSED SYSTEM LEAKING BLOOD FROM THE LINE ONTO THE PATIENT AND BED. PATIENT WAS HEP LOCKED AND CAP CHANGE WAS COMPLETED. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22072764 ↗
• MalfunctionJan 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A 4" (10 CM) APPX 0.89 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHECK VALVE, 3 CLAMPS (2 WHITE, RED), ROTATING LUER WAS FOUND TO HAVE BECOME DETACHED DURING PATIENT USE. THE REPORT STATES THAT "THE CUSTOMER STATED THAT THEY HAVE BROKEN TRIFUSE. TRIFUSE ATTACHED TO CVL EXTENSION BECAME SPONTANEOUSLY DETACHED DURING MIXED VENOUS BLOOD WORK. UNABLE TO REATTACH TRIFUSE. NEW TRIFUSE OBTAINED AND REATTACHED TO CVL EXTENSION WITHOUT INCIDENT." THE EVENT OCCURRED IN THE PAEDIATRIC ICU (ROOM# 11 AT CVL EXTENSION SITE). THE DEFECTIVE ITEM WAS SAVED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280464 ↗
• MalfunctionNov 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A 4" (10 CM) SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHECK VALVE, 3 CLAMPS (2 WHITE, RED), ROTATING LUER WAS FOUND TO HAVE PULLED APART DURING PATIENT USE. THE REPORTER STATED THAT THE TRIFUSE TENTACLE THAT THE LINE WAS CONNECTED TO, WAS THE RED BACKFLOW PORT, WHILE REPOSITIONING THE PATIENT, THE TACRO LINE CONNECTED TO THE TRIFUSE WAS PULLED TAUT AND PULLED THE CAP OFF THE TRIFUSE PORT. THE ENTIRE CAP CAME OFF OF THE TRIFUSE. IT WAS CONFIRMED WITH THE BEDSIDE NURSE THAT UNFORTUNATELY THE TUBING FROM THE EVENT WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS DURING/AFTER USE. THE OCCURRENCE AND THE AFFECTED QUANTITY ARE ONE. THE COMPLAINT CATEGORY IS DAMAGED/BROKEN. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE CUSTOMER IS NOT REQUESTING AN RGA. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587944 ↗
• MalfunctionAug 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" (10 CM) APPX 0.89 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHECK VALVE, 3 CLAMPS (2 WHITE, RED), ROTATING LUER. IT WAS REPORTED THAT PATIENT WAS CONNECTED TO LINES AT 2140H AND AROUND 2150H THEY NOTICED BED BEING WET UNDERNEATH THE LINES. NOTICED LEAKING WITHIN 10 MINS OF PATIENT BEING CONNECTED TO TOTAL PARENTERAL NUTRITION (TPN) AND SMOFLIPID. THE INFUSION WAS STOPPED BY THE NURSE AND REPLACED THE ENTIRE TRIFUSE WITH NEW LINES. THERE WAS A PATIENT INVOLVED AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075903 ↗
• MalfunctionJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" (10 CM) SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHECK VALVE, 3 CLAMPS (2 WHITE, RED), ROTATING LUER WHERE THE CUSTOMER REPORTED THAT TOTAL PARENTERAL NUTRITION (TPN) AND SMOF WERE INFUSING THROUGH TRIFUSE INTO COIL TO PATIENT AND IT WAS NOTED THAT THERE WAS NO SMOF IN COIL. UPON INSPECTION BY THE CUSTOMER, THEY NOTED SMOF WAS LEAKING FROM TRIFUSE AND NONE ENTERING COIL; THE CUSTOMER DISCONNECTED SMOF AND MADE NEW LINES AND SMOF LUMEN NOTED TO BE CROOKED AND NOT IN PROPER POSITION. THE NURSE FLUSHED PORT OF TRIFUSE AND IT WAS NOTED TO BE LEAKING BELOW MICROCLAVE CAP, AND THE MICROCLAVE CAP APPEARS NOT BE SECURED THE SAME AS THE OTHER LUMENS. THE NURSE NOTICED THE LEAK WITHIN THE HOUR OF PATIENT BEING CONNECTED TO INFUSION AS PATIENT HAD COIL EXTENSION TUBING ON AND NO SMOF WAS FOUND IN THE COIL EXTENSION TUBING. SMOF WAS INFUSING @7.5ML/H SO NURSE IDENTIFIED THAT LEAK WAS NOT NOTICEABLE UNTIL PATIENT HAD MORE TIME CONNECTED TO INFUSION AND THEY PROMPTLY CHANGED LINES WHEN LEAKING WAS NOTICED, AND THEY CONTINUE TO MONITOR FOR ANY SIGNS OF CENTRAL LINE BLOODSTREAM INFECTION (CLABSI). THE EVENT HAPPENED AT 2000H DURING INFUSION. THERE WAS PATIENT INVO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559287 ↗
• MalfunctionJun 5, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHECK VALVE, 3 CLAMPS (2 WHITE, RED), ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THEY FOUND CAP/TRIFUSE CRACKED AND BROKEN OFF DURING PATIENT INFUSION IN THE PICU AT 19:30H. THE CUSTOMER REPORTED THAT THE BED WAS WET ON FIRST ASSESSMENT; THEY IMMEDIATELY CLAMPED THE LINE, CHANGED THE CAP IN A STERILE MANNER AND CLEANSED FOR AN EXTRA 15SECONDS WITH ALCOHOL. THE LINES WERE CHANGED AND RECONNECTED. THE CUSTOMER STATED THAT THE CAP APPEARED TO HAVE WHITE AREAS AS IF PRECIPITATE HAD BEEN IN THE CAP. THEY WERE RUNNING CONCENTRATED LASIX INFUSION WITH MAINTENANCE. THE DATE THE LINE WAS PLACED WAS ON (B)(6) 2024. THE MATING DEVICE WAS A DOUBLE LUMEN CV LINE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467221 ↗
• MalfunctionMay 2, 2024Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  THE EVENT INVOLVED A 4" (10 CM) APPX 0.89 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHECK VALVE, 3 CLAMPS (2 WHITE, RED), ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE PATIENT WAS WITH THERAPEUTIC HEPARIN TUBING ATTACHED TO A SMALLBORE TRIFUSE EXTENSION WHICH WAS ITSELF ATTACHED TO A PERIPHERAL INTRAVENOUS (IV). THE PERIPHERAL IV SITE HAD BEEN PREVIOUSLY ASSESSED WITH TUBING FOLLOWED FROM SYRINGE TO PATIENT. WHEN THE PATIENT WAS SETTLING TO BED AND STATED THE FOLLOWING ¿COULD I HAVE SOMETHING TO KEEP THIS IV TUBING DRY.¿ IT WAS THEN INVESTIGATED AND FELT SOME MOISTURE ON THE BLOOD PORT OF THE TRIFUSE EXTENSION; PRODUCT WAS REMOVED AND SYRINGE WAS ATTACHED DIRECTLY TO THE PERIPHERAL IV WHEREIN THE IV SITE WAS REASSESSED WITH SALINE FLUSH. UPON FURTHER INSPECTION, IT WAS DISCOVERED THAT THE SILICONE STOPPER ON THE END OF THE BLOOD PORT OF THE TRIFUSE EXTENSION WAS FULLY DEPRESSED AND IF FLUIDS WERE PUSHED INTO THE OTHER "ARMS" OF THE EXTENSION PIECE, THERE WAS A DOWNWARD OCCLUSION (THE CUSTOMER PLACED A CAP ON THE END OF THE EXTENSION TO CHECK THIS) AND FLUID WOULD LEAK OUT OF THE DEPRESSED SILICONE FROM THE BLOOD PORT. ADDITIONALLY, THE CUSTOMER STATED THAT THE TRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230673 ↗

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-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-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-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(
• Z-0239-2021 · Jul 6, 2020 · Terminated
  APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(1
• Z-0231-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709080796(17)241201(30)50(10)4536743; (01)1088770908
• Z-0235-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50(10)4565730; (01)10887709067322(
• 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-0254-2021 · Jul 6, 2020 · Terminated
  22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10
• 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.

…and 173 more.