ICU Medical, Inc. MC330716Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00887709127364), received between Nov 18, 2025 and Sep 15, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776849 ↗
• MalfunctionJul 20, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25877183 ↗
• MalfunctionJun 21, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A 102 INCH (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE SMALLBORE W CLAVE CLEAR, SPIROS W RED CAP, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK. IT WAS REPORTED THAT THE FILTER (SMALL, UPPER, IN-LINE) WAS FOUND LEAKING TO AMINO ACID DEXTROSE SOLUTION ADMINISTRATION TUBING DURING THE AFTERNOON LINE CHECK (AT 1300H). THE EVENT OCCURRED DURING INFUSION. THERE WERE A PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572588 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A SMALLBORE TRANSFER SET, AND UPON INVESTIGATION OF THE DEVICE, LEAKAGE OF INFUSATE WAS IDENTIFIED. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED. THIS EVENT CAPTURES SECOND OF THE RETURNED FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556290 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A SMALLBORE TRANSFER SET, AND UPON INVESTIGATION OF THE DEVICE, LEAKAGE OF INFUSATE WAS IDENTIFIED. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED. THIS EVENT CAPTURES THIRD OF THE RETURNED FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556289 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A SMALLBORE TRANSFER SET, AND UPON INVESTIGATION OF THE DEVICE, LEAKAGE OF INFUSATE WAS IDENTIFIED. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED. THIS EVENT CAPTURES FIRST OF THE RETURNED FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556288 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A SMALLBORE TRANSFER SET, AND UPON INVESTIGATION OF THE DEVICE, LEAKAGE OF INFUSATE WAS IDENTIFIED. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED. THIS EVENT CAPTURES FOURTH OF THE RETURNED FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556282 ↗
• MalfunctionMar 9, 2026Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED WHERE THE CUSTOMER CONFIRMED THAT THE AADS THAT WAS USED DURING THE REPORTED ISSUE WAS AMINO ACIDS DEXTROSE SOLUTION AND THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542668 ↗
• MalfunctionFeb 8, 2026Fluid/Blood Leak

  THIS EMDR REFLECTS THE FIFTH USED SAMPLE FAILURE FOR THE ORIGINAL COMPLAINT THAT WAS REPORTED FOR ONLY ONE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288373 ↗
• MalfunctionFeb 8, 2026Fluid/Blood Leak

  THIS EMDR REFLECTS THE FOURTH USED SAMPLE FAILURE FOR THE ORIGINAL COMPLAINT THAT WAS REPORTED FOR ONLY ONE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288369 ↗
• MalfunctionFeb 8, 2026Fluid/Blood Leak

  THIS EMDR REFLECTS THE THIRD USED SAMPLE FAILURE FOR THE ORIGINAL COMPLAINT THAT WAS REPORTED FOR ONLY ONE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288361 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak

  THIS EMDR REFLECTS THE SECOND USED SAMPLE FAILURE FOR THE ORIGINAL COMPLAINT THAT WAS REPORTED FOR ONLY ONE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24285003 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  THE EVENT INVOLVED THE FOLLOWING MEDICAL DEVICE: 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLEAR, SPIROS¿ W/RED CAP, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK. THE 1.2 MICRON FILTER IN THE IV SET WAS LEAKING DESPITE A NEW LOT #. LEAKAGE OCCURRED AT VARIOUS HANG TIMES DURING PATIENT USE. ALL SOLUTIONS RUNNING WERE PARENTERAL NUTRITION. THE SETS FAILED MULTIPLE TIMES. THERE WAS NO HARM TO THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259328 ↗
• MalfunctionDec 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVED A 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLEAR, SPIROS¿ W/RED CAP, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK REPORTED THAT THE 1.2-MICRON FILTER WAS LEAKING ON IV(INTRAVENOUS) TUBING PARENTAL SOLUTION. THE SETS FAILED MULTIPLE TIMES. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886850 ↗
• MalfunctionDec 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING A 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLEAR, SPIROS¿ W/RED CAP, AN EVENT INVOLVED A 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLEAR, SPIROS¿ W/RED CAP, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK REPORTED THAT THE FILTER WAS LEAKING DURING USE WITH "AADS". THE EVENT HAPPENED MULTIPLE TIMES AND CAUSES UNEXPECTED OR PROLONGED CARE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886083 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN INCIDENT INVOLVING EXT SET BIFUSE PUR STANDARDBORE REPORTED THAT "AADS" FILTER OF TUBING LEAKING AT SHIFT CHANGE SAFETY CHECK. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824937 ↗
• MalfunctionDec 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN INCIDENT INVOLVING A SMALLBORE TRANSFER SET REPORTED THAT THE "AADS" FILTER IS LEAKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813017 ↗
• MalfunctionDec 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVED A 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLEAR, SPIROS¿ W/RED CAP, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK REPORTED THAT THE 1.2-MICRON FILTER ADJACENT TO THE 2-WAY VALVE LEAKING. NO PATIENT HARM REPORTED. YES, PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799933 ↗
• MalfunctionDec 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE CLEAR, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK AND IT WAS REPORTED THAT THE "AADS" LINE FILTER LEAKING. ABLE TO CHANGE OUT LINE AS 2-PIECE SETUP WAS USED AND NO INTERRUPTION TO INFUSION. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799908 ↗
• MalfunctionNov 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLEAR, SPIROS¿ W/RED CAP, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK WHERE THE CUSTOMER REPORTED THAT DURING FIRST 5 DAYS OF IMPLEMENTATION, FREQUENT FAILURE (UNSPECIFIED QUANTITY) OF THE 1.2 MICRON IN-LINE AIR FILTER ON THE MEDFUSION SETS WAS LEAKING PARENTERAL NUTRITION. THE LEAK WAS COMING FROM THE AIR VENTS OCCUR WITHIN 24 HOURS OF PRIMING. THE SAMPLE WAS CONNECTED TO TRANSFER SET W/0.2 MICRON FILTER, CLAVE. B33984. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625688 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE CLEAR, SPIROS W/RED CAP, DUAL CHECK VALVE, 1.2 MICRON FILTER, LUER LOCK AND IT WAS REPORTED THAT THE ANTIARRHYTHMIC DRUGS (AADS) LINE FILTER FOUND TO BE LEAKING AT TIME OF CHANGE FOR NEW BAG. FILTER TO DISTAL END, AFTER SYRINGE LEAKING, WIPED CLEAN AND REMAINED LEAKING AFTER. THIS NEW AADS LINE WAS SET UP WITH THE NEW FILTER ATTACHMENT TO PROXIMAL END OF LINE AND FOUND TO BE LEAKING AFTER 1 DAY AFTER IT HAD BEEN CHANGED. NEW AADS LINE SET UP WITH NEW FILTER. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590388 ↗

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-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-0210-2021 · Jul 6, 2020 · Terminated
  13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)108
• Z-0199-2021 · Jul 6, 2020 · Terminated
  9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)455847
• 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-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-0254-2021 · Jul 6, 2020 · Terminated
  22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10
• Z-0198-2021 · Jul 6, 2020 · Terminated
  107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(
• Z-0229-2021 · Jul 6, 2020 · Terminated
  78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The I

…and 173 more.