ICU Medical MC330428Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709088344), received between Sep 30, 2022 and Jun 24, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

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

  THE EVENT INVOLVED A 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE), ROTATING LUER. THE REPORTER STATED THAT, WHEN THE BEDSIDE RN'S STUDENT ATTEMPTED TO PUSH MORPHINE AT THE TOP OF THE LINE, THE BIFUSE WAS STILL CLAMPED AT THE BOTTOM. WHEN THE MORPHINE WAS ATTEMPTED TO BE PUSHED, IT INSTEAD REPORTEDLY LEAKED OUT THROUGH THE BOTTOM OF THE CLAVE AT THE TOP OF THE LINE AND DRIPPED ONTO THE FLOOR. THE BEDSIDE RN CHECKED THAT IT WAS SCREWED ON PROPERLY BY THE STUDENT, AND IT WAS. THE ENTIRE IV LINE WAS DISCONNECTED, MORPHINE WAS PULLED BACK OUT OF THE LINE, AND THE REMAINDER WASTED. A NEW DOSE WAS OBTAINED FOR THE PATIENT, AND A NEW LINE WAS PRIMED. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321763 ↗
• MalfunctionJan 10, 2025Disconnection; Disconnection

  THE EVENT INVOLVED A 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE), ROTATING LUER WHERE THE REPORTER STATED THAT UPON DISCONNECTING A MED LINE FROM A BIFUSE ATTACHED TO A PATIENT'S PED'S PICC, THE LINE DISCONNECTED IN AN UNUSUAL WAY. UPON FURTHER INSPECTION, PART OF THE MED LINE REMAINED FUSED TO THE BIFUSE, THE TUBING AND PIECE THAT SCREWS ONTO THE BIFUSE CONNECTOR BOTH DETACHED. BASICALLY, THE MED LINE SOMEHOW ENDED UP IN 3 PIECES. THERE WAS PATIENT INVOLVEMENT, THERE WAS NO SIGNIFICANT DELAY IN THERAPY AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122724 ↗
• MalfunctionSep 17, 2024Air/Gas in Device; Air/Gas in Device

  A COMPLAINT INVOLVING A 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE), ROTATING LUER EXPERIENCED AIR IN LINE. THE REPORTER STATED THAT THEIR PATIENT WAS GETTING IV ANTIBIOTICS VIA SYRINGE PUMP. THE NS FLUSH WAS PLACED ON THE PUMP AFTER THE ANTIBIOTIC WAS DONE INFUSING AND FLUSH STARTED. PATIENT'S MOTHER THEN NOTICED ABOUT 6 INCHES OF AIR IN THE LINE AFTER THE NS FLUSH STARTED. THEY UNHOOKED THE LINE FROM THE PATIENT SO THAT NO AIR GOT THROUGH THE IV AND INTO THE PATIENT. THE PATIENT'S MOTHER ALSO STATED THAT THIS EXACT SITUATION HAPPENED THE NIGHT BEFORE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT OR STAFF HARM / INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20243161 ↗
• MalfunctionMay 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE), ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH THEIR CLAVES ON THE ARTERIAL LINE. THE CUSTOMER STATED THAT THEY HAD DRAWN BLOOD THROUGH THE CLAVE AND WENT TO FLUSH IT; THE CLAVE WOULD NOT CLEAR OF BLOOD AND UPON CLOSER OBSERVATION THE INNER PLASTIC WAS LEAKING AND BLOOD WAS IN BETWEEN THE INNER PLASTIC AND OUTER PLASTIC. IT DID NOT LEAK TO THE OUTSIDE. THE CUSTOMER CHANGED CLAVES AND HAD THIS EXPERIENCE THREE TIMES. THE CLAVES WERE CHANGED AGAIN, AND WITHOUT INCIDENT. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19291233 ↗
• MalfunctionSep 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE), ROTATING LUER WHICH THE CUSTOMER REPORTED THAT THE MEDICATION LINE WAS LEAKING FROM THE POINT OF CONNECTION. TYLENOL AND A FLUSH HAD BEEN RUN BEFORE THE SMALL LEAK WAS NOTICED. IT WAS NOT SPECIFIED IF THERE WAS PATIENT INVOLVEMENT OR NOT, HOWEVER, NO INJURY WAS REPOTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814785 ↗
• MalfunctionSep 30, 2022Disconnection; Mechanical Problem; Disconnection; Mechanical Problem

  A USER FACILITY MANDATORY MEDWATCH REPORT # 4633010000-2022-8019 WAS RECEIVED THAT STATED: "HEALTH CARE PROVIDER WAS SWITCHING THE NOREPINEPHRINE SYRINGE PER PROTOCOL USING THE TWO SYRINGE METHOD AND EXTENSION TUBING. AFTER HAVING THE SECOND SYRINGE RUNNING FOR 15 MINS TO MAKE SURE IT WAS ENGAGED, HEALTH CARE PROVIDER WENT TO DISCONNECT THE TUBING FROM THE FIRST EXTENSION ON THE NOREPINEPHRINE TUBING AND AS HEALTH CARE PROVIDER PULLED ON THE CLAVE AND TUBING, THE TUBING DISCONNECTED FROM THE CLAVE. HEALTH CARE PROVIDER THEN HAD TO RE PRIME NEW TUBING FOR THE NOREPINEPHRINE SYRINGE. PATIENT WAS RUNNING AT 0.07MCG/KG/HR. AND HIS BLOOD PRESSURE DROPPED FROM MEAN ARTERIAL PRESSURE (MAPS) OF 75 TO MAPS OF 55. HEALTH CARE PROVIDER WAS ABLE TO QUICKLY RECONNECT AND GET IT RUNNING AGAIN BUT IT TOOK ABOUT 6-8 MINS TO SEE A BUMP IN PATIENT'S BLOOD PRESSURE AGAIN. WHILE THIS WAS NOT IMMEDIATELY LIFE THREATENING FOR THIS SPECIFIC PATIENT IF HE WAS MORE SENSITIVE TO CHANGES IN THIS MEDICATIONS IT COULD HAVE REQUIRED MUCH MORE INTERVENTION AND POSSIBLY CODING THE PATIENT". THE EVENT OCCURED IN THE PICU AND INVOLVED A 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE),

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 15519843 ↗

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-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-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-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-0194-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(0
• 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-0188-2021 · Jul 6, 2020 · Terminated
  10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri-Connector, NanoClave T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouche
• 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-0251-2021 · Jul 6, 2020 · Terminated
  60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780. The Intravascular Ad

…and 173 more.