ICU Medical B33983Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887709127166), received between Dec 31, 2024 and Jun 24, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 6.5" (17 CM) APPX 0.59 ML, SMALLBORE BIFUSE EXT SET, W/CLAVE¿, CHECK VALVE, 2 CLAMPS (RED, WHITE), LUER LOCK THAT REPORTEDLY LEAKED AN UNSPECIFIED FLUID/INFUSATE. THE FACILITY WILL NO LONGER USE THIS DEVICE BECAUSE OF THE LEAKAGE ISSUE. THE TOTAL AFFECTED PRODUCT AMOUNT WAS 2 CASES AND THEY HAVE REQUESTED CREDIT. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323331 ↗
• MalfunctionMar 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  RECEIVED ADDITIONAL INFORMATION: THE REPORTER STATED THAT THEY HAVE DEFECTIVE PRODUCTS THAT ARE STILL ON HAND. THERE WAS UNKNOWN DELAY IN THERAPY REPORTED. THE TOTAL AFFECTED PRODUCT WERE 16 CASES.

  Patient problems: Insufficient Information

  MAUDE report 21639159 ↗
• MalfunctionMar 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A 6.5" (17 CM) APPX 0.59 ML, SMALLBORE BIFUSE EXT SET, W/CLAVE¿, CHECK VALVE, 2 CLAMPS (RED, WHITE), LUER LOCK EXPERIENCED LEAKING NEAR THE CONNECTION PIECE WHERE THE BIFURCATION SPLITS OFF. THERE WAS NO PATIENT HARM REPORTED. THIS IS ONE OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556108 ↗
• MalfunctionMar 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A 6.5" (17 CM) APPX 0.59 ML, SMALLBORE BIFUSE EXT SET, W/CLAVE¿, CHECK VALVE, 2 CLAMPS (RED, WHITE), LUER LOCK EXPERIENCED LEAKING NEAR THE CONNECTION PIECE WHERE THE BIFURCATION SPLITS OFF. THERE WAS NO PATIENT HARM REPORTED. THIS IS TWO OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556107 ↗
• MalfunctionDec 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 5.5" (14 CM) APPX 0.57 ML, SMALLBORE BIFUSE EXT SET W/REMV CHECK VALVE, 2 CLAMPS (WHITE, RED), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THE PRODUCT WAS LEAKING NEAR THE CONNECTION PIECE WHERE THE BIFURCATION SPLITS OFF. THE EVENT OCCURRED DURING PATIENT USE. 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 21047569 ↗

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-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-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-0184-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI: (01)10887709051031(
• 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-0207-2021 · Jul 6, 2020 · Terminated
  13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)
• 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-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-0219-2021 · Jul 6, 2020 · Terminated
  113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per
• 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

…and 173 more.