ICU Medical MC330375Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00887709085671), received between Oct 4, 2023 and Sep 13, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK GENERATED A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE PRODUCT PROBLEM WAS LEAKING TOTAL PARENTAL NUTRITION (TPN). THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214985 ↗
• MalfunctionSep 13, 2024No Flow; No Flow

  IT WAS REPORTED THAT A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK WAS FOUND TO HAVE AN OCCLUSION DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE PRODUCT PROBLEM WAS ALL LINES PRIMED AND INFUSING. THE LIPID PORT STARTED RINGING OCCLUSION AND WOULD NOT CLEAR. QUADFUSE CHANGED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214246 ↗
• MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK GENERATED A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE PRODUCT PROBLEM WAS LEAKING TOTAL PARENTAL NUTRITION (TPN). THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213787 ↗
• MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK GENERATED A LEAKOF TOTAL PARENTAL NUTRITION (TPN) DURING PATIENT USE. THERE WAS NO BLOOD LOSS AND NO UNPROTECTED CHEMO EXPOSURE. THERE WERE NO ADVERSE OPERATOR CONSEQUENCES AND NO MED/SURG INTERVENTION REQUIRED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20209367 ↗
• MalfunctionSep 13, 2024No Flow; No Flow

  IT WAS REPORTED THAT A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK GENERATED AN OCCLUSION DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE PRODUCT PROBLEM WAS THE LIPID FILTER CLOGGED. THE EVENT OCCURRED DURING AN INFUSION OF TOTAL PARENTERAL NUTRITION (TPN) LIPIDS. THERE WAS NO BLOOD LOSS AND NO UNPROTECTED CHEMO EXPOSURE. THERE WERE NO ADVERSE OPERATOR CONSEQUENCES AND NO MED/SURG INTERVENTION REQUIRED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20209206 ↗
• MalfunctionSep 12, 2024No Flow; No Flow

  IT WAS REPORTED THAT A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK WAS FOUND TO BE OCCLUDED DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE PRODUCT PROBLEM WAS LIPIDS OCCLUDED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207767 ↗
• MalfunctionSep 11, 2024No Flow; No Flow

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK WAS FOUND TO HAVE AN OCCLUSION DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE PRODUCT CLOGGED PEDI PALL FILTERS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192525 ↗
• MalfunctionAug 15, 2024No Flow; No Flow

  THE EVENT INVOLVED A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK WHERE IT WAS REPORTED THAT THE 0.2 MICRON FILTER IS OCCLUDED. THE EVENT OCCURRED DURING INFUSION OF TOTAL PARENTERAL NUTRITION (TPN). NO BLOOD LOSS, UNPROTECTED CHEMO EXPOSURE AND NO ADVERSE OPERATOR CONSEQUENCES. THERE WAS PATIENT INVOLVED, NO SERIOUS INJURY OR DEATH AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19994805 ↗
• MalfunctionJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK IN WHICH THE CUSTOMER REPORTED THAT THE DEVICE LEAKED AT LOCATION OF THE CLAVE AND IV TUBING CONNECTION POINT. THE MATING DEVICES WERE SYRINGE, MONITOR, CATHETER, AND THE MEDICATION INVOLVED WAS TOTAL PARENTERAL NUTRITION (TPN). THE CUSTOMER STATED THAT THE QUADFUSE WAS IN USE FOR TPN ADMINISTRATION. PT WITH BEDSIDE GLUCOSE OF 16 AT 0501. D10 BOLUS ORDERED BY PROVIDER AND GIVEN AT 0533. THE NURSE NOTED AT AROUND 0540 THAT THERE WAS QUITE A BIT OF FLUID ON THE LINEN AND THE FLUID SMELLED LIKE TPN. UPON FURTHER INVESTIGATION BY THE CUSTOMER, THE QUADFUSE WAS NOTED TO BE LEAKING NEAR LEUR LOCK CONNECTION SITE (RIGHT BEFORE MICROCLAVE CONNECTION). THE QUADFUSE WAS CHANGED OUT AND ANOTHER D10 BOLUS GIVEN. THERE WAS NO BLOOD LOSS AND NO UNPROTECTED CHEMO EXPOSURE. THERE WAS NO ADVERSE OPERATOR CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584502 ↗
• MalfunctionFeb 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER WHICH WAS REPORTED TO LEAK DURING PATIENT USE FROM THE PROXIMAL CONNECTION POINT, RIGHT ABOVE (DISTAL TO THE COLLAR). THERE WAS PATIENT INVOLVEMENT AND REPORTED DELAY IN THERAPY; THERE WAS NO ADVERSE PATIENT OR OPERATOR CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED. THIS IS REPORT FIVE OF FIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697289 ↗
• MalfunctionFeb 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER WHICH WAS REPORTED TO LEAK DURING PATIENT USE FROM THE PROXIMAL CONNECTION POINT, RIGHT ABOVE (DISTAL TO THE COLLAR). THERE WAS PATIENT INVOLVEMENT AND REPORTED DELAY IN THERAPY; THERE WAS NO ADVERSE PATIENT OR OPERATOR CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED. THIS IS REPORT FOUR OF FIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697081 ↗
• MalfunctionFeb 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER WHICH WAS REPORTED TO LEAK DURING PATIENT USE FROM THE PROXIMAL CONNECTION POINT, RIGHT ABOVE (DISTAL TO THE COLLAR). THERE WAS PATIENT INVOLVEMENT AND REPORTED DELAY IN THERAPY; THERE WAS NO ADVERSE PATIENT OR OPERATOR CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED. THIS IS REPORT THREE OF FIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696805 ↗
• MalfunctionFeb 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER WHICH WAS REPORTED TO LEAK DURING PATIENT USE FROM THE PROXIMAL CONNECTION POINT, RIGHT ABOVE (DISTAL TO THE COLLAR). THERE WAS PATIENT INVOLVEMENT AND REPORTED DELAY IN THERAPY; THERE WAS NO ADVERSE PATIENT OR OPERATOR CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED. THIS IS REPORT TWO OF FIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696705 ↗
• MalfunctionFeb 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER WHICH WAS REPORTED TO LEAK DURING PATIENT USE FROM THE PROXIMAL CONNECTION POINT, RIGHT ABOVE (DISTAL TO THE COLLAR). THERE WAS PATIENT INVOLVEMENT AND REPORTED DELAY IN THERAPY; THERE WAS NO ADVERSE PATIENT OR OPERATOR CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED. THIS IS REPORT ONE OF FIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696547 ↗
• MalfunctionOct 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK WHERE IT WAS REPORTED THROUGH INVESTIGATION, THAT ONE SAMPLE WAS CONFIRMED TO HAVE A BONDING CHANNEL LEAK. THE PROBABLE CAUSE OF THE LEAK IS TYPICAL OF INSUFFICIENT SOLVENT COVERAGE DURING MANUAL ASSEMBLY. ACCORDING TO THE ORIGINAL COMPLAINT PROVIDED BY THE CUSTOMER THE EVENT WAS NOT DETECTED PRIOR TO DIRECT PATIENT USE. THERE WAS NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, AND NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE OPERATOR CONSEQUENCES AND NO DELAY IN CRITICAL THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17870293 ↗

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-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-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-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-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-0187-2021 · Jul 6, 2020 · Terminated
  7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108877090510
• Z-0221-2021 · Jul 6, 2020 · Terminated
  83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. UDI:(01)10887709089508(17)250101(30)25(10)45
• Z-0242-2021 · Jul 6, 2020 · Terminated
  11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(
• Z-0215-2021 · Jul 6, 2020 · Terminated
  29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case. UDI:(01)10840619082533(17)250101(30)50(10)4605138. The Intravascular Admi
• Z-0249-2021 · Jul 6, 2020 · Terminated
  6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)108877090

…and 173 more.