ICU Medical B1003Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709000018), received between May 7, 2024 and Oct 17, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Crack; Crack

  THE EVENT INVOLVED A 6" BIFUSE EXT SET W/2 CHECK VALVES, ROTATING LUER WHERE IT WAS REPORTED THAT IV TUBING CRACKED AND BROKE WHILE ATTACHED TO THE PATIENT. THERE WAS NO SERIOUS HARM AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328479 ↗
• MalfunctionJun 28, 2024Crack; Crack

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 6" BIFUSE EXT SET W/2 CHECK VALVES, ROTATING LUER. THE REPORTER STATED THAT THE SPIN COLLAR CRACKED ON WHILE IN USE WITH PROPOFOL. THERE WAS NO REPORT OF HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639629 ↗
• MalfunctionMay 8, 2024Fluid/Blood Leak; Separation Failure; Fluid/Blood Leak; Separation Failure

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 6" BIFUSE EXT SET W/2 CHECK VALVES, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THEY HAVE HAD AT LEAST 4 DEVICES BREAK AT THE LUER ADAPTER MALE END AND THAT AT LEAST 2 INSTANCES WERE THE PATIENT DID NOT RECEIVE THEIR IV MEDICATIONS FOR AT LEAST 30 MINUTES CAUSING CLINICAL DETERIORATION. THE NURSES DID NOT OVER-TIGHTEN THE DEVICE TO THE PATIENT¿S IV CATHETER. THE PATIENT¿S NOREPINEPHRINE INFUSION AND VASOPRESSIN INFUSIONS WERE NOT INFUSING CAUSING THE PATIENT¿S BLOOD PRESSURE TO DROP TO 65/42, THE INFUSIONS WERE RESTARTED AND THE PATIENT IMPROVED OVER THE COURSE OF THE NEXT 30 MINUTES. THE DEVICE WAS FOUND BROKEN (NOT WHEN LUER LOCKING TO IV CATHETER). THERE WAS PATIENT INVOLVEMENT, BUT NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271669 ↗
• MalfunctionMay 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 6" BIFUSE EXT SET W/2 CHECK VALVES, ROTATING LUER THAT REPORTEDLY BROKE (IN SITU) WHILE IT WAS CONNECTED TO A PATIENT¿S IV ACCESS DURING A PROPOFOL INFUSION. THIS RESULTED IN A LEAK OF INTRAVENOUS PROPOFOL ONTO THE BED. THERE WAS NO HUMAN HARM REPORTED ASSOCIATED WITH THE EVENT. HOWEVER, THE EVENT WAS REPORTED TO BE A 'NEAR MISS' BECAUSE THE PATIENT BECAME VERY AGITATED, THEIR BLOOD PRESSURE WENT UP TO A SYSTOLIC OF 200, AND THE PATIENT ALMOST SELF-EXTUBATED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 19263068 ↗

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-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-0200-2021 · Jul 6, 2020 · Terminated
  12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case. UDI: (01)10887709070100(17)250101(30)50(10)45727
• Z-0206-2021 · Jul 6, 2020 · Terminated
  60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit p
• Z-0249-2021 · Jul 6, 2020 · Terminated
  6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)108877090
• 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-0236-2021 · Jul 6, 2020 · Terminated
  7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)1088770906
• 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-0224-2021 · Jul 6, 2020 · Terminated
  3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50

…and 173 more.