ICU Medical CH3067Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619024345), received between May 16, 2024 and May 17, 2024 — classified as 2 malfunctions.

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

• MalfunctionMay 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 41 CM (16") PUR CLEAR/YELLOW BIFUSE ADD-ON SET W/CLAVE®, DRY SPIKE ADAPTER WHICH THE CUSTOMER REPORTED LEAKED DURING PATIENT USE. THE CUSTOMER STATED THAT ONE MINUTE AFTER INTRODUCTION OF THE CYTOTOXIC (BUSULFAN) THERE WAS DISINTEGRATION OF THE TUBING DOWNSTREAM OF THE VALVE. THE DEVICE WAS CHANGED. THERE IS NO INFORMATION AVAILABLE REGARDING THE PATIENT'S STATE. THE TREATMENT WAS FULLY ADMINISTERED. THERE WAS NO LOSS OF BLOOD. THE MEDICATION CAME INTO CONTACT WITH THE PATIENT AND THE HEALTHCARE PROVIDER BUT NOTHING TO REPORT REGARDING THE EFFECTS ON THEM. THE LEAK WAS CLEANED ACCORDING TO FACILITY¿S PROTOCOL. THERE WAS NO VISIBLE DEFAULT NOTED ON THE DEVICE BEFORE USE BUT A HOLE/CUT/TEAR WAS NOTED 1 MINUTE AFTER ADMINISTERING THE CYTOTOXIC. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345725 ↗
• MalfunctionMay 16, 2024Material Integrity Problem; Material Integrity Problem

  THE EVENT INVOLVED A 41 CM (16") PUR CLEAR/YELLOW BIFUSE ADD-ON SET W/CLAVE®, DRY SPIKE ADAPTER WHERE IT WAS REPORTED ONE MINUTE AFTER INTRODUCTION OF THE CYTOTOXIC (BUSULFAN) THERE WAS DISINTEGRATION OF THE TUBING DOWNSTREAM OF THE VALVE. PROJECTION OF CYTOTOXIC ONTO THE HEALTHCARE PROVIDER. THE PATIENT DID NOT RECEIVE THE ENTIRE DOSE (2ML MISSING APPROXIMATELY) AND THE DEVICE WAS CHANGED, TREATMENT WAS THEN FULLY ADMINISTERED. THE MEDICATION CAME INTO CONTACT WITH THE PATIENT AND THE HEALTHCARE PROVIDER BUT NOTHING TO REPORT REGARDING THE EFFECTS ON THEM. THE LEAK WAS CLEANED UP ACCORDING TO THE FACILITY¿S PROTOCOL. NO SPECIFIC KIT. NO VISIBLE DEFAULT ON THE DEVICE BEFORE USE (DEVICE CHECKED BEFORE USE). A HOLE/CUT/TEAR WAS NOTED 1 MINUTE AFTER ADMINISTERING THE CYTOTOXIC. THERE WAS NO NEED FOR MEDICAL INTERVENTION. NOBODY WAS HARMED BUT THE NURSE WAS EXPOSED TO A CYTOTOXIC. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331230 ↗

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-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-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-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-0245-2021 · Jul 6, 2020 · Terminated
  126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062365(17)250201(30)25(10)4630752. The Intrav
• Z-0211-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.UDI:(01)
• Z-0246-2021 · Jul 6, 2020 · Terminated
  40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709014531(17)250101(30)50
• Z-0235-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50(10)4565730; (01)10887709067322(
• 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-0186-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)
• 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

…and 173 more.