ICU Medical MC3325Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709037540), received between Oct 18, 2023 and Sep 8, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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.

• MalfunctionSep 8, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676374 ↗
• MalfunctionAug 11, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211383 ↗
• MalfunctionMar 24, 2025Material Rupture; Material Rupture

  THE EVENT INVOLVED A 7" (18CM) APPX 0.69ML EXT SET W/REMV MICROCLAVE¿ CLEAR, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED DURING CT CONTRAST INJECTION, THE SIDE OF THE IV EXTENSION RUPTURED RESULTING IN THE PATIENT NOT GETTING ENOUGH CONTRAST AND HAVING TO GO BACK FOR A SECOND CT WITH CONTRAST. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO SERIOUS HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21681721 ↗
• MalfunctionOct 9, 2024Material Separation; Material Separation

  THE COMPLAINT/EVENT INVOLVED A 7" (18CM) APPX 0.67ML EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER. UPON CHECKING ON THE PATIENT IN THE AM, SALINE EXTENSION LUER LOCK CAP WAS NO LONGER IN SITU ON THE IV EXTENSION AND LINE WAS OPEN. IT WAS ALSO NOTICED ON MULTIPLE LINES THAT THE PORT HAS BEEN FALLING OFF. IT WAS REQUIRED TO STICK THE PATIENT AGAIN, AND THIS WAS ATTEMPTED SIX TIMES THE DAY BEFORE. COMMUNITY PARAMEDICS NEEDED TO BE CALLED TO INITIATE THE SAME ON PATIENT. THERE WAS NO HUMAN HARM AND THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20411851 ↗
• MalfunctionOct 19, 2023No Flow; No Flow

  THE EVENT INVOLVED A 7" (18CM) APPX 0.67ML EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER WHERE THE CUSTOMER USED THIS DEVICE FOR ALL OF THEIR INTRAVENOUS (IV'S) IN ENDOSCOPY. FROM THERE WHEN TRYING TO HOOK UP THE IV FLUID LINE TO THE EXTENSION LOCK AND YOU CANNOT PUSH MEDS THROUGH THE IV. IF YOU TAKE THE EXTENSION CAP OFF AND RUN THE IV THE TUBING DIRECT TO THE LINE IT WILL WORK. THE PROBLEM IS RECURRING. ADDITIONALLY, THE CUSTOMER STATED THAT AN IV FLUID WAS RINGERS LACTATE AND THEN THEY TRIED TO PUSH PROPOFOL AND FENTANYL BUT COULD NOT PUSH. ONCE THEY REMOVED THE LOCK DEVICE AND HOOK THE IV UP DIRECTLY, THEY COULD PUSH THE MEDICATION. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967511 ↗
• MalfunctionOct 18, 2023Fluid/Blood Leak; Separation Failure; Fluid/Blood Leak; Separation Failure

  THE EVENT INVOLVED A 7" (18CM) APPX 0.69ML EXT SET W/REMV MICROCLAVE¿ CLEAR, CLAMP, ROTATING LUER IN WHICH THE CUSTOMER REPORTED THAT WHILE DRAWING BLOODWORK WITH A SALINE LOCK, THE END OF THE LUER LOCK (ATTACHED THE TUBING) BLEW OFF INDEPENDENTLY WHILE STILL ATTACHED TO THE VACUTAINER. THE VACUTAINER WITH THE LAVENDER SYRINGE WAS THROWN ONTO THE FLOOR AND BLOOD FROM THE PATIENT SPRAYED ON TO THE FLOOR AND BLOOD WAS DRIPPING FROM THE PATIENT (UNSPECIFIED AMOUNT). THE SALINE TUBING WAS CLAMPED OFF, ANOTHER MEMBER OF STAFF WAS CALLED TO GET ADDITIONAL SUPPLIES. THERE WERE NO DEFECTS NOTED ON THE TUBING SET BEFORE IT WAS USED. THE TUBING WAS REPLACED AND THERAPY RESUMED. THE INCIDENT OCCURRED DURING PATIENT USE (IN ISOLATION) BUT NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961479 ↗

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-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-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-0200-2021 · Jul 6, 2020 · Terminated
  12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case. UDI: (01)10887709070100(17)250101(30)50(10)45727
• 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-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-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
• Z-0196-2021 · Jul 6, 2020 · Terminated
  7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Luer. UDI:(01)10887709067049(17)2
• 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-0185-2021 · Jul 6, 2020 · Terminated
  5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.

…and 173 more.