ICU Medical B1415Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709001565), received between Mar 11, 2025 and May 12, 2026 — classified as 2 malfunctions.

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

• MalfunctionMay 12, 2026Disconnection

  A COMPLAINT WAS RECEIVED REGARDING A 6" (15 CM) APPX 1.7 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CHECK VALVES, 4 CLAMPS, ROTATING LUER IN WHICH IT WAS REPORTED THAT DURING 07:30 HR LINE TRACING, THE UVC [ABBREVIATION NOT SPECIFIED] SECONDARY LUMEN END WAS FOUND DISCONNECTED IN THE BED. THE DISCONNECTION WAS FROM THE GREEN UVC CATHETER HUB TO THE EXTENSION TUBING, PROXIMAL TO THE BLUE NEUTRON. THE INFUSION HAD BEEN PREVIOUSLY LOCKED FROM THE PUMP AFTER A MEDICATION WAS LAST ADMINISTERED AT APPROXIMATELY 05:00 HRS. NO BLOOD LOSS WAS NOTED ON THE BED SHEETS, AND NO WET FLUID WAS OBSERVED. IMMEDIATE INTERVENTION BY THE WRITER WAS TO CLAMP THE LINE CLOSED, SCRUB IT WITH CHLOROPREP, AND CAP THE END WITH A BLUE NEUTRON. ALL OTHER CONNECTIONS WERE CHECKED AND TRACED. THE INCIDENT INVOLVED TWO PIECES OF EQUIPMENT THE UMBILICAL CATHETER AND THE EXTENSION SET AND IT WAS AT THIS JUNCTION THAT THE DISCONNECTION HAD OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25154155 ↗
• MalfunctionMar 11, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 7" SMALLBORE EXT SET W/CLAMP, ROTATING LUER THAT REPORTEDLY DETACHED FROM THE IV (INTRAVENOUS) LINE AND LEAKED DURING A BABY'S INFUSION. THE REPORTER STATED THAT THE BABY WAS PLACED INTO HOLD AT 1600H WITH HIS MOTHER. THE LINES WERE CLAMPED TO HIS MOM'S GOWN, WITH PLENTY OF SLACK. AT 1800H, WHILE PREPARING TO MOVE THE BABY BACK TO BED, THE CLINICIAN NOTICED WETNESS NEAR THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) SITE. IT WAS FURTHER OBSERVED THAT THE PICC HUB WAS OPEN TO AIR, AND THE EXTENSION SET (BETWEEN THE PICC AND NEUTRON) HAD FULLY DETACHED FROM THE LINE. NO HARM OR ADVERSE EVENT WAS REPORTED WITH RESPECT TO THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575245 ↗

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-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-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-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-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-0194-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(0
• Z-0251-2021 · Jul 6, 2020 · Terminated
  60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780. The Intravascular Ad
• 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-0230-2021 · Jul 6, 2020 · Terminated
  114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer, 2 Exts. 1 unit per pouch, 25 pouches per
• Z-0187-2021 · Jul 6, 2020 · Terminated
  7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108877090510

…and 173 more.