ICU Medical CH3557Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709076389), received between Jul 26, 2023 and Aug 31, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.

• MalfunctionAug 31, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531350 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED WITH SCAR 000825 REPORT REGARDING A 12" (30 CM) APPX 2.4 ML, EXT SET W/MICROCLAVE, CHECK VALVE IN WHICH IT WAS REPORTED THAT THERE WAS A LEAK FROM BREACH IN TUBING LINE. THIS OCCURRED DURING CELL CULTURE FOR A PATIENT AND NO HARM AS REPORTED. MANUFACTURING OPERATORS OBSERVED ABOUT 3ML OF CELL CULTURE LEAK FROM THE CELL CULTURE BAG FROM THE SAMPLE PORT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164561 ↗
• MalfunctionAug 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 12" (30 CM) APPX 2.4 ML, EXT SET W/MICROCLAVE¿, CHECK VALVE GENERATED A LEAK DURING PATIENT USE. IT WAS REPORTED THAT THE TUBING AREA NEAR THE CHECK VALVE HAD A SMALL DROPLET, INDICATING A BREACH IN THE TUBING LINE. THE EVENT OCCURRED DURING THE SAMPLING OPERATION. LIQUID DROPLETS WERE OBSERVED COMING FROM THE TUBING AREA NEAR THE FILTER PORT, AND IT WAS DETECTED ON THE TUBING IMMEDIATELY ABOVE THE FILTER CONNECTION NEAR THE HEAT-SEALED END. NO ABRASIONS WERE OBSERVED NEAR THE DEFECT. THE FRACTURE SURFACES ARE SLIGHTLY ROUGH ¿ NO CLEAR PERFORATION MECHANISM IS APPARENT, BUT IT DOES NOT APPEAR TO BE CONSISTENT WITH CONTACT BY A BLADED INSTRUMENT. NO ADDITIONAL LEAKS WERE DETECTED IN THE SAMPLE. A SAMPLE PHOTO WAS PROVIDED SHOWING THE AFFECTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883070 ↗
• MalfunctionJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 12" (30 CM) APPX 2.4 ML, EXT SET W/MICROCLAVE¿, CHECK VALVE WHERE IT WAS REPORTED THAT MANUFACTURING ASSOCIATES PERFORMED SAMPLE COLLECTION PER WORKFLOW. WHILE PERFORMING SAMPLE COLLECTION THEY NOTICED A LEAK WAS COMING FROM THE BASE OF THE CHECK VALVE OF THE SAMPLING SYSTEM CLOSED PLASTIC STERILE 2.2ML, (ORACLE#: 108651, INTERNAL LOT#:SM0705328, SUPPLIER LOT#:5943362) WHICH IS WELDED ONTO THE BIOREACTOR BAG AS A SAMPLE PORT. A HEMOSTAT WAS IMMEDIATELY PLACED ON THE LINE CLOSE TO THE CELL BAG AND THE SAMPLING PORT CLAMP WAS CLOSED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401053 ↗

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-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-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-0196-2021 · Jul 6, 2020 · Terminated
  7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Luer. UDI:(01)10887709067049(17)2
• 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-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
• Z-0223-2021 · Jul 6, 2020 · Terminated
  26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The I
• Z-0227-2021 · Jul 6, 2020 · Terminated
  142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948
• Z-0207-2021 · Jul 6, 2020 · Terminated
  13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)
• Z-0259-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.39 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)1

…and 173 more.