ICU Medical 011-MC3323Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619043247), received between Mar 13, 2025 and Mar 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025No Flow; No Flow

  A COMPLAINT WAS RECEIVED REGARDING A 6" (15CM) APPX 0.49 ML SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 4 CLAMPS, ROTATING LUER THAT EXPERIENCED NO FLOW DURING USE. THE REPORTER STATED, "MALFUNCTIONS IN THE FUNCTIONING OF THE TWO- AND THREE-WAY MICRO CLAVE EXTENSION, WHICH MANIFESTS ITSELF AS HEMODYNAMIC INSTABILITY OF THE PATIENT AND THE ERROR MESSAGE ¿ ¿OCCLUSION ON THE PERFUSOR¿. WHEN THE EXTENSION IS REPLACED, THE PATIENT'S CONDITION NORMALIZES. THE PROBLEM HAS OCCURRED IN SEVERAL CASES." THE EVENT OCCURED DURING INFUSION. THE NUMBER OF INVOLVED PROBLEMATIC DEVICE ARE MULTIPLE. NO SERIOUS INJURY OR DEATH. THERE WAS DELAY IN CRITICAL THERAPY. NO ADVERSE OPERATOR CONSEQUENCES AND NO MED/SURG INTERVENTION REQUIRED. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THE PRODUCT IS STORED IN THE STORAGE AREA, MONITORED AND HAS ALL THE NECESSARY CERTIFICATIONS (ISO STANDARDS ETC.) THERE WERE NO CUTS, HOLES, DEFECTS NOTED ON THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21647797 ↗
• MalfunctionMar 13, 2025Disconnection; Disconnection

  THE EVENT INVOLVED A 6" (15CM) APPX 0.49 ML SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 4 CLAMPS, ROTATING LUER. IT WAS REPORTED THAT THE SAFETY VALVE STAYED OPEN ON AN INADVERTENT DISCONNECT ALLOWING CENTRAL VENOUS ACCESS DEVICE (CVAD) TO BE OPEN TO AIR. SOMEONE BECAME AWARE OF THE ISSUE WHEN THE STAFF NOTICED THAT THE VALVE WAS STUCK DOWN UPON DISCONNECTION. PROPOFOL AND FENTANYL WERE THE MEDICATIONS BEING USED ON THE PATIENT AT THE TIME. THERE WAS AN UNSPECIFIED DELAY IN THERAPY, HOWEVER THERE WAS NO ADVERSE EVENT/HARM AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599285 ↗

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-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
• Z-0216-2021 · Jul 6, 2020 · Terminated
  54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, n
• Z-0224-2021 · Jul 6, 2020 · Terminated
  3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50
• 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-0203-2021 · Jul 6, 2020 · Terminated
  8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30
• 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-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

…and 173 more.