ICU Medical B33098Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887709006263), received between Oct 4, 2018 and May 14, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Leak/Splash; Leak/Splash

  THE COMPLAINT/EVENT INVOLVED A 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, ROTATING LUER. ONE TRIFUSE OF THE DEVICE WAS SQUIRTING SALINE DURING A FLUSH. AS ADDITIONAL INFORMATION, WHEN CHANGING DRESSING PACK FOR THE PATIENT, THEY ALSO NOTICED BLOOD BACKING INTO THE TUBING DURING THE FLUSH. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019042 ↗
• MalfunctionApr 11, 2024Disconnection; Disconnection

  THE EVENT INVOLVED A 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿, 3 CLAMPS, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THEY ARE HAVING THE LUER TRIPLE SETS DISCONNECTING FROM CVL CLAVES. OTHER PRODUCTS INVOLVED AT THE TIME OF EVENT WERE MC100 AND B3300. THE PRODUCT WAS IN USE FOR FEW HOURS WHEN DISCONNECTION WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM OR ADVERSE EVENT, AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087757 ↗
• MalfunctionJul 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, ROTATING LUER WHERE THE UNSPECIFIED CHEMOTHERAPY THAT WAS INFUSING VIA TRIFUSE LEAKED OUT JUNCTION OF THE SPIROS THAT WAS ATTACHED. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065873 ↗
• MalfunctionMar 29, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT INVOLVED 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, ROTATING LUER THAT THE CUSTOMER REPORTED AN UNKNOWN SUBSTANCE INSIDE ONE OF THE TRIFUSE. THE DEVICE WAS STORED IN A SUPPLY ROOM. THERE WAS PATIENT INVOLVEMENT AND NO REPORT OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582021 ↗
• MalfunctionNov 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A LEAK OF CYTARABINE CHEMOTHERAPY FROM THE HUB OF A TRIFUSE SET WHERE ALL THREE LINES MEET. THE LEAK CAME INTO CONTACT WITH THE PATIENT, HOWEVER, THERE WAS NO REPORT OF HARM, OR THE NEED FOR A MEDICAL INTERVENTION.

  Patient problems: Chemical Exposure

  MAUDE report 9304172 ↗
• MalfunctionApr 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A PATIENT WAS RECEIVING 24 HOUR CHEMOTHERAPY WHEN A MICROCLAVE ON A TRIFUSE EXTENSION SET REMAINED DEPRESSED AND STARTED LEAKING FLUID. NO ADVERSE EVENT WAS REPORTED; HOWEVER, THE PATIENT HAD A CENTRAL LINE AND HAD AN EARLIER THAN NORMAL TUBING CHANGE DUE TO AN INCREASED RISK OF INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8537264 ↗
• MalfunctionOct 4, 2018Material Separation; Material Separation

  THE EVENT INVOLVED A CUSTOMER REPORT STATING THAT ONE LUMEN OF A SMALLBORE TRIFUSE EXTENSION SET W/3 MICROCLAVE BECAME DETACHED AT THE HUB ALLOWING FOR FREE FLOWING BACKFLOW FROM THE CENTRAL LINE. THERE WAS NO SERIOUS INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7934478 ↗

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-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-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-0195-2021 · Jul 6, 2020 · Terminated
  109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotati
• Z-0240-2021 · Jul 6, 2020 · Terminated
  11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI:(01)10887709088354(17)250101(30)50(10)4557643. The Intrava
• 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-0211-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.50 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)
• 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-0205-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080703(17)250101(30)5
• 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

…and 173 more.