ICU Medical B1434Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709001657), received between Sep 20, 2017 and Jun 20, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionJun 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT INVOLVED A 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER. IT WAS REPORTED THAT THE FILTER NOTED TO BE LEAKING AT 2 POINTS ON THE BACK OF FILTER. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS USE ON PATIENT. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT BUT THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299722 ↗
• MalfunctionNov 21, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO A 8" (20CM) SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER THAT EXPERIENCED BREAKAGE AND LEAKAGE. THE REPORTER STATED THAT LEAKING FLUIDS, CRACK AT CONNECTION POINT. TUBING WAS CHANGED. OCCURRED WHILE IN USE WITH PATIENT. NO INJURY, HARM OR DEATH REPORTED. COMPLAINT QUANTITY IS ONE. SAMPLE WAS DECONTAMINATED. THE EVENT DATE WAS ON 12-OCT-2024. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING USE ON A PATIENT. THERE WAS NO ADVERSE EVENT AND NO INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754156 ↗
• MalfunctionSep 18, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER. THE REPORTER STATED THAT THEIR IV FILTERS HAVE BEEN CAUSING MULTIPLE OCCLUSION ALARMS. THEY HAVE TRIED TO RECTIFY THIS BY CHANGING OUT THE FILTERS, BUT THEY ARE ALSO CAUSING OCCLUSION ALARMS. THE PUMP ALARMED AND OCCLUDED 20 MINUTES AFTER ATTACHING TO THE BABY. THEY TRIED TO INCREASE THE PRESSURE TO 100, AND IT ALARMED AFTER ONE MINUTE. WHEN NOT ATTACHED TO THE BABY, IT ALARMED AS PRESSURE WENT UP. THEY TOOK THE FILTER OFFLINE, THERE WAS NO ALARM AND PRESSURE WAS LOW. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SOMETIMES OCCLUSION ALARM SOUNDS BEFORE CONNECTED TO THE PATIENT, SOMETIMES ALARM SOUNDS AFTER IT'S BEEN CONNECTED TO THE PATIENT. THE FILTER IS CONNECTED TO BD ALARIS TUBING. TO STOP THE ALARM THE FILTER IS EITHER REMOVED COMPLETELY FROM THE LINE OR THE PRESSURE SETTING ON THE PUMP IS INCREASED TO STOP THE ALARM WITH THE FILTER REMAINING IN LINE. THEY HAVE THEIR PRESSURES SET TO 75 BUT WILL OCCASIONALLY INCREASE TO 125 FOR THE ALARM TO TURN OFF THE ALARM OR REMOVE THE FILTER COMPLETELY FROM THE LINE. WHEN REMOVED TO FLUSH TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764492 ↗
• MalfunctionSep 20, 2017Leak/Splash; Leak/Splash

  COMPLAINT RECEIVED REGARDING TWO B1434, REPORT STATES: DURING CHEMOTHERAPY (ETOPOSIDE) INFUSION, MEDICATION NOTED TO BE LEAKING @ FLAT SECTION OF FILTER. THIS HAPPENED ON TWO SEPARATE DAYS ON THE SAME PATIENT. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6879463 ↗

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-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-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-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-0244-2021 · Jul 6, 2020 · Terminated
  128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887
• Z-0245-2021 · Jul 6, 2020 · Terminated
  126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062365(17)250201(30)25(10)4630752. The Intrav
• 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-0256-2021 · Jul 6, 2020 · Terminated
  149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;
• Z-0191-2021 · Jul 6, 2020 · Terminated
  5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101
• Z-0196-2021 · Jul 6, 2020 · Terminated
  7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Luer. UDI:(01)10887709067049(17)2

…and 173 more.