ICU Medical B1701Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709068476), received between Dec 31, 2024 and Dec 31, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS EMDR RECORD CAPTURED TWO OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21049178 ↗
• MalfunctionDec 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE 4" (10 CM) SMALLBORE TRIFUSE EXT SET W/2 REMV CHECK VALVES, 3 CLAMPS (RED, YELLOW, WHITE), LUER LOCK, NON DEHP TUBING HAD A LEAK ISSUE. IT WAS STATED THAT THE DEVICE STARTED TO LEAK AT THE JUNCTION WITH FLUSHING. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING PATIENT USE. INFORMATION ON SPECIFIC FLUID OR MEDICATION IS NOT AVAILABLE. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND POSSIBLE DELAY IN THERAPY DUE TO HAVING TO REPLACE LINE/EXTENSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21049010 ↗
• MalfunctionDec 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE 4" (10 CM) SMALLBORE TRIFUSE EXT SET W/2 REMV CHECK VALVES, 3 CLAMPS (RED, YELLOW, WHITE), LUER LOCK, NON DEHP TUBING HAD A LEAK ISSUE. IT WAS STATED THAT THE DEVICE STARTED TO LEAK AT THE JUNCTION WITH FLUSHING. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING PATIENT USE. INFORMATION ON SPECIFIC FLUID OR MEDICATION IS NOT AVAILABLE. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND POSSIBLE DELAY IN THERAPY DUE TO HAVING TO REPLACE LINE/EXTENSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21049002 ↗
• MalfunctionDec 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" (10 CM) SMALLBORE TRIFUSE EXT SET W/2 REMV CHECK VALVES, 3 CLAMPS (RED, YELLOW, WHITE), LUER LOCK, NON DEHP TUBING WHERE THE CUSTOMER REPORTED THAT THE DEVICE WAS LEAKING BELOW CAPS. THE EVENT OCCURRED DURING PATIENT USE, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THE VENT. THERE WAS POSSIBLE DELAY IN THERAPY DUE TO HAVING TO REPLACE LINE/EXTENSIONS. INFORMATION ON SPECIFIC FLUID OR MEDICATION IS NOT AVAILABLE. THERE WERE 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048197 ↗
• MalfunctionDec 31, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" (10 CM) APPX 0.77 ML, SMALLBORE TRIFUSE EXT SET W/2 REMV CHECK VALVES, 3 CLAMPS (RED, YELLOW, WHITE), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THAT THE DEVICE WAS CRACKED AND LEAKING. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND POSSIBLE DELAY IN THERAPY DUE TO HAVING TO REPLACE LINE/EXTENSIONS. INFORMATION ON SPECIFIC FLUID OR MEDICATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047440 ↗
• MalfunctionDec 31, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" (10 CM) APPX 0.77 ML, SMALLBORE TRIFUSE EXT SET W/2 REMV CHECK VALVES, 3 CLAMPS (RED, YELLOW, WHITE), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THE DEVICE WAS CRACKED AND LEAKING. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND POSSIBLE DELAY IN THERAPY DUE TO HAVING TO REPLACE LINE/EXTENSIONS. INFORMATION ON SPECIFIC FLUID OR MEDICATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047351 ↗

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-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-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-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-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-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
• Z-0223-2021 · Jul 6, 2020 · Terminated
  26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The I
• Z-0190-2021 · Jul 6, 2020 · Terminated
  9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053004(17)250101(30)50
• 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-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
• 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.