ICU Medical CH3700Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709089181), received between Jan 30, 2024 and Jun 18, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 5.5" (14 CM) APPX 0.55 ML, SMALLBORE TRIFUSE EXT SET W/3 CHEMOCLAVE¿, SPIROS¿ W/RED CAP, 3 CLAMPS WHERE THE REPORTER STATED THAT DURING INFUSION, WHEN THEY CLAMP THE PINCH CLAMPS, THEY AREN'T CLAMPING DOWN ALL THE WAY AND FLUID IS ABLE TO ESCAPE INTO THE OTHER LUMENS. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284552 ↗
• MalfunctionMar 3, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A 5.5" (14 CM) APPX 0.55 ML, SMALLBORE TRIFUSE EXT SET W/3 CHEMOCLAVE®, SPIROS® W/RED CAP, 3 CLAMPS WAS FOUND TO HAVE SEPARATED DURING PATIENT USE. THE REPORT STATED THAT THE SPIROS AT THE END OF THE TRIFUSE POPS OFF OF THE TUBING. FOUND AS THEY TRIED TO HOOK IT UP AND START CHEMO. IT WILL ATTACH BUT IF YOU BARELY TOUCH/SPIN IT, IT FALLS OFF THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511422 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  THE EVENT INVOLVED A 5.5" (14 CM) APPX 0.55 ML, SMALLBORE TRIFUSE EXT SET W/3 CHEMOCLAVE¿, SPIROS¿ W/RED CAP, 3 CLAMPS THE REPORTED ISSUE WAS TRIFUSE TUBING DISCONNECTED FROM BONDED SPIROS. IVF RUNNING AT TIME OF EVENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611363 ↗

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-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-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-0234-2021 · Jul 6, 2020 · Terminated
  47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01
• 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-0237-2021 · Jul 6, 2020 · Terminated
  20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(10)4742130; (01)10887709069203(1
• Z-0189-2021 · Jul 6, 2020 · Terminated
  9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(0
• Z-0239-2021 · Jul 6, 2020 · Terminated
  APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(1
• Z-0238-2021 · Jul 6, 2020 · Terminated
  11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)1
• Z-0233-2021 · Jul 6, 2020 · Terminated
  139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)1088

…and 173 more.