ICU Medical MC33892Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709070790), received between Feb 28, 2022 and Apr 7, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Free or Unrestricted Flow” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2022Free or Unrestricted Flow; Free or Unrestricted Flow

  THE EVENT INVOLVED A 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE® CLEAR, ROTATING LUER. A MEDSUN MANDATORY AND VOLUNTARY MEDWATCH REPORT FORM (B)(4) WAS RECEIVED THAT STATED THAT THE "CLOSED MEDICATION ADMINISTRATION INFUSION SET BEING UTILIZED ON UNIT FOR MEDICATION ADMINISTRATION WITH FLUSH TO FOLLOW FOR INFUSION VIA CENTRAL LINES." THE MEDWATCH REPORT FURTHER STATES THAT "NORMAL SALINE BAG ATTACHED TO SET, INTENDED TO ALLOW FOR FLUSH FLUID TO BE PULLED INTO SYRINGE VIA ONE WAY VALVE HAS INADVERTENTLY INFUSED INTO THE PATIENT. VOLUME OF 90-180ML ADDITIONAL ADMINISTERED OVER SEVERAL HOURS THAT WAS NOT INTENDED." THE CUSTOMER FURTHER CLARIFIED THAT THE REPORTED EVENT OCCURRED IN THE HOSPITAL. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO HUMAN HARM. THIS CAPTURES THE FIRST OF TWO EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047613 ↗
• MalfunctionApr 7, 2022Free or Unrestricted Flow; Free or Unrestricted Flow

  THE EVENT INVOLVED A 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE® CLEAR, ROTATING LUER. A MEDSUN MANDATORY AND VOLUNTARY MEDWATCH REPORT FORM ((B)(4)) WAS RECEIVED THAT STATED THAT THE "CLOSED MEDICATION ADMINISTRATION INFUSION SET BEING UTILIZED ON UNIT FOR MEDICATION ADMINISTRATION WITH FLUSH TO FOLLOW FOR INFUSION VIA CENTRAL LINES." THE MEDWATCH REPORT FURTHER STATES THAT "NORMAL SALINE BAG ATTACHED TO SET, INTENDED TO ALLOW FOR FLUSH FLUID TO BE PULLED INTO SYRINGE VIA ONE WAY VALVE HAS INADVERTENTLY INFUSED INTO THE PATIENT. VOLUME OF 90-180ML ADDITIONAL ADMINISTERED OVER SEVERAL HOURS THAT WAS NOT INTENDED." THE CUSTOMER FURTHER CLARIFIED THAT THE REPORTED EVENT OCCURRED IN THE HOSPITAL. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO HUMAN HARM. THIS CAPTURES THE SECOND OF TWO EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047609 ↗
• MalfunctionFeb 28, 2022Inaccurate Delivery; Inaccurate Delivery

  THE EVENT INVOLVED A 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE® CLEAR, ROTATING LUER WHICH WAS REPORTED TO HAVE OVER-INFUSED. THE CUSTOMER REPORTED THAT THE PATIENT'S CLOSED MEDICATION SET INFUSED 250ML OF NORMAL SALINE INTO PATIENT BETWEEN 2200 ON (B)(6) 2022 AND 0500 ON (B)(6) 2022. BASED ON THE PATIENT MEDICATION SCHEDULE, THE PATIENT SHOULD HAVE ONLY RECEIVED 60ML OF NORMAL SALINE BETWEEN THOSE TIMES. A PUMP WAS NOT USED WITH THE SET. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT. THE PATIENT CONDITION IS STABLE. THIS EVENT DID NOT PROLONG THE PATIENT'S HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624776 ↗

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-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-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-0214-2021 · Jul 6, 2020 · Terminated
  99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515
• 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-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-0185-2021 · Jul 6, 2020 · Terminated
  5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.
• Z-0190-2021 · Jul 6, 2020 · Terminated
  9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053004(17)250101(30)50
• 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
• Z-0219-2021 · Jul 6, 2020 · Terminated
  113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per

…and 173 more.