ICU Medical CH3699Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709089174), received between Dec 11, 2018 and Jan 30, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA A MEDSUN MEDWATCH MANDATORY AND VOLUNTARY REPORT UF/IMPORTER REPORT # (B)(4) THAT A 5.5" (14 CM) APPX 0.37 ML, SMALLBORE BIFUSE EXT SET W/2 CHEMOCLAVE®, SPIROS® W/RED CAP, 2 CLAMPS GENERATED A LEAK DURING PATIENT USE. THE REPORT STATED: ¿THE PATIENT GOT UP FROM HIS BED TO USE THE BATHROOM. HE HAD UNHOOKED HIS WOUND VACUUM-ASSISTED CLOSURE (VAC), WHICH ALARMED TO CAUSE ME TO COME SEE WHAT HAPPENED. I CALLED AH TO ENSURE THAT THE PATIENT WAS OKAY TO DO SO. I HAD STARTED HIS METHOTREXATE (MTX). AT [TIME REDACTED], THE PATIENT RETURNED TO HIS BED, I NOTICED THAT SOMETHING WAS WET ON HIS SHORTS. I THOUGHT IT WAS JUST FROM THE SINK OF HIM WASHING HIS HANDS. HOWEVER, WHEN I CAME BACK 10 MINUTES LATER TO CHECK HIS WOUND VAC WAS RECONNECTED PROPERLY WITH MY CHARGE NURSE. I THEN NOTICED THAT THE WET SPOT ON HIS SHORTS HAD TURNED A NEON YELLOW AND THERE WERE MORE SPOTS. I THEN RAISED THE PART OF HIS SHORTS TO FIND THAT HIS LEG HAD SPOTS OF A YELLOW LIKE PASTE IN WHICH I KNEW IT WOULD HAVE TO BE THE MTX. I CALLED MY CHARGE NURSE BACK TO THE ROOM, PAGED THE TEAM AND PHARMACY TO ENSURE THE CORRECT ACTIONS WERE TAKEN AND THE TECH TO COME ASSIST IN AN EXPOSURE BATH. WE CLEANED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280124 ↗
• MalfunctionAug 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 5.5" (14 CM) APPX 0.37 ML, SMALLBORE BIFUSE EXT SET W/2 CHEMOCLAVE®, SPIROS® W/RED CAP, 2 CLAMPS WHERE IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR CHEMO; TYPICAL SET UP WITH HAZARDOUS MEDLINE, HAZARDOUS SYRINGE, AND MIVF LINE WITH A TRIFUSE SPIROS AT THE END. PREPARED LINE BY RESOURCE RN. SPIROS CLICKED INTO PLACE AND ABLE TO SWIVEL WITH A C-CLAMP ON. PATIENT HAD ALREADY INFUSED FLUID BOLUSES AND THEN TOOK A WALK IN THE HALLWAY. IN THE HALLWAY BLOOD STARTED TO BACK UP INTO PATIENT LINE AND LEAK OUT OF THE HAZARDOUS MEDLINE AT THE SITE OF THE SPIROS WHILE PATIENT WAS RIDING A TOY CAR. PATIENT STOPPED AND LINE WAS DISCONNECTED FROM TRIFUSE AND HAZARDOUS MEDLINE WAS SAVED TO GIVE TO MANAGEMENT. THERE WAS PATIENT INVOLVEMENT AND NO INJURY.

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

  MAUDE report 19934011 ↗
• MalfunctionDec 18, 2018Disconnection; Disconnection

  IT WAS REPORTED, ON AN UNSPECIFIED DATE, THE EXTENSION SET DISCONNECTS AT THE CONNECTION POINTS AND CAN SPRAY CHEMO CHEMICALS ON PATIENT AND STAFF. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PATIENT USE. THERE WAS UNKNOWN PATIENT HARM REPORTED. AS ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 8175239 ↗
• MalfunctionDec 11, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A SMALLBORE BIFUSE EXT SET W/2 CHEMOCLAVE®, SPIROS® W/RED CAP, 2 CLAMPS THAT DURING DISCONNECTION A LEAK OF VINCRISTINE WAS NOTICED. THERE WAS PATIENT INVOLVEMENT, DRUG EXPOSURE TO THE PATIENT, FAMILY, AND STAFF, UNKNOWN ADVERSE EVENT, AND A POTENTIAL RISK FOR CENTRAL LINE ASSOCIATED BLOODSTREAM INFECTION (CLABSI). NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Chemical Exposure

  MAUDE report 8152274 ↗

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-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-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-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-0225-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088501(17)250201(30)25(10)4733705.
• Z-0253-2021 · Jul 6, 2020 · Terminated
  60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. The Intravascular
• 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-0208-2021 · Jul 6, 2020 · Terminated
  12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(3
• Z-0206-2021 · Jul 6, 2020 · Terminated
  60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit p
• 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.