ICU Medical B33381Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887709008069), received between Oct 22, 2019 and Mar 27, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 118" (300 CM) APPX 9.3 ML, TRANSFER SET W/ANTI-SIPHON VALVE, 3-WAY STOPCOCK, 2 MICROCLAVE®, 0.2 MICRON FILTER, LUER LOCK WHERE THE CUSTOMER REPORTED THAT THEY HAVE HAD LEAKS ON THE DEVICE AT THE LOCATION OF THE FILTERS ON AND OFF THE LAST FEW MONTHS. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING USE ON PATIENT. THE MEDICATION BEING USED WITH THIS PRODUCT IS CHEMOTHERAPEUTIC AGENT. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE AND IT WAS CONTAMINATED WITH BIOHAZARD OR CHEMOTHERAPEUTIC AGENT. THERE WAS PATIENT INVOLVEMENT; THERE WAS DELAY IN THERAPY.BUT NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708681 ↗
• MalfunctionMay 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 118" (300 CM) APPX 9.3 ML, TRANSFER SET W/ANTI-SIPHON VALVE, 3-WAY STOPCOCK, 2 MICROCLAVE®, 0.2 MICRON FILTER, LUER LOCK WHERE THE CUSTOMER REPORTED LEAKING ON 4 SETS DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM, NO ADVERSE EVENTS AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342342 ↗
• MalfunctionSep 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 118" (300 CM) APPX 9.3 ML, TRANSFER SET W/ANTI-SIPHON VALVE, 3-WAY STOPCOCK, 2 MICROCLAVE®, 0.2 MICRON FILTER, LUER LOCK GENERATED A LEAKING FILTER. REGISTERED NURSE (RN) AND NURSE PRACTITIONER (NP) STATED THIS WAS THE THIRD ONE LEAKING FOR THIS PATIENT. THE MEDICATION LEAKING WAS TPN. THERE WAS PATIENT INVOLVEMENT HOWEVER, NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699104 ↗
• MalfunctionOct 22, 2019Mechanical Problem; Mechanical Problem

  THE EVENT OCCURRED ON AN UNKNOWN DAY IN (B)(6) 2019. THE CLAVE ON THE PREPARED TUBING WAS NOT SECURE AND TRAINED AIR INTO LINE. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO ADVERSE EVENT. THIS REPORT CAPTURES THE FOURTH OF 4 INCIDENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217807 ↗
• MalfunctionOct 22, 2019Mechanical Problem; Mechanical Problem

  THE EVENT OCCURRED ON AN UNKNOWN DAY IN (B)(6) 2019. THE CLAVE ON THE PREPARED TUBING WAS NOT SECURE AND TRAINED AIR INTO LINE. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO ADVERSE EVENT. THIS REPORT CAPTURES THE THIRD OF 4 INCIDENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217781 ↗
• MalfunctionOct 22, 2019Mechanical Problem; Mechanical Problem

  THE EVENT OCCURRED ON AN UNKNOWN DAY IN (B)(6) 2019. THE CLAVE ON THE PREPARED TUBING WAS NOT SECURE AND TRAINED AIR INTO LINE. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO ADVERSE EVENT. THIS REPORT CAPTURES THE SECOND OF 4 INCIDENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217779 ↗
• MalfunctionOct 22, 2019Mechanical Problem; Mechanical Problem

  THE EVENT OCCURRED ON AN UNKNOWN DAY IN (B)(6) 2019. THE CLAVE ON THE PREPARED TUBING WAS NOT SECURE AND TRAINED AIR INTO LINE. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO ADVERSE EVENT. THIS REPORT CAPTURES THE FIRST OF 4 INCIDENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217775 ↗

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-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-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-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-0184-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI: (01)10887709051031(
• Z-0228-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709089904(17)250101(30)25(10)4713954.
• Z-0232-2021 · Jul 6, 2020 · Terminated
  58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460
• Z-0216-2021 · Jul 6, 2020 · Terminated
  54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, n
• 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-0241-2021 · Jul 6, 2020 · Terminated
  6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)2501
• Z-0258-2021 · Jul 6, 2020 · Terminated
  112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case

…and 173 more.