ICU Medical MC33193Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709057616), received between Apr 24, 2025 and May 9, 2025 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX. 0.7 ML SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR (RED, GLOW RINGS), 0.2 MICRON FILTER, 3 CLAMPS (RED, WHITE, BLUE), ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE PRODUCT WAS LEAKING FROM THE FILTER, WHILE CONNECTED TO THE PICC LINE ON A PATIENT. HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997882 ↗
• InjuryApr 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX. 0.7 ML SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR (RED, GLOW RINGS), 0.2 MICRON FILTER, 3 CLAMPS (RED, WHITE, BLUE), ROTATING LUER. THE DEVICE WAS REPORTEDLY LEAKING TOTAL PARENTERAL NUTRITION FROM THE DEVICE'S FILTER. THE FLUID CONSISTENTLY LEAKED ONLY AT THE FILTER LOCATION. A SEPSIS DIAGNOSIS AND DECLINING STATUS OCCURRED AFTER THE LEAKING ITEMS WERE FOUND AND THE PATIENT REQUIRED INTUBATION WITH CONVENTIONAL VENTILATION AND THAT ULTIMATELY ESCALATED TO HIGH FREQUENCY VENTILATION. A FULL SEPSIS WORK UP INCLUDING SPUTUM CULTURE, URINE CULTURE, BLOOD CULTURE, LUMBAR PUNCTURE WAS ORDERED AND PERFORMED. THEY STOPPED THE PATIENT'S PARENTERAL FEEDINGS/OPTIMAL NUTRITION BECAUSE MANY LABS AND MULTIPLE XRAYS WERE REQUIRED TO IDENTIFY INFECTION AND MONITOR THE PATIENT'S STATUS AND PROGRESSION. FURTHER MEDICAL INTERVENTION INCLUDED MEDICATION DRIPS TO SUPPORT BLOOD PRESSURE AND THE INITIATION OF ANTIBIOTIC THERAPY. THE CRACKS OR BREAKS WERE NOT VISIBLE. THE ISSUE WAS NOTED AFTER THE DEVICES WERE CONNECTED TO THE PATIENT. FLUIDS/MEDS WERE BEING INFUSED WHEN THE LINENS AND TUBING WERE NOTED TO BE WET. T

  Patient problems: Sepsis; Ventilator Dependent

  MAUDE report 21914215 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX. 0.7 ML SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR (RED, GLOW RINGS), 0.2 MICRON FILTER, 3 CLAMPS (RED, WHITE, BLUE), ROTATING LUER. THIS PRODUCT WAS REPORTEDLY LEAKING AN UNSPECIFIED FLUID/INFUSATE FROM THE FILTER. THERE WAS NO HARM TO THE PATIENT AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900516 ↗

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-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-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-0241-2021 · Jul 6, 2020 · Terminated
  6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)2501
• Z-0198-2021 · Jul 6, 2020 · Terminated
  107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(
• Z-0232-2021 · Jul 6, 2020 · Terminated
  58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460
• 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-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-0247-2021 · Jul 6, 2020 · Terminated
  7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravasc
• Z-0229-2021 · Jul 6, 2020 · Terminated
  78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The I

…and 173 more.