ICU Medical B33982Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887709127159), received between Dec 31, 2024 and Jun 24, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 9 most recent of 9 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 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES, 4 CLAMPS (RED, WHITE, GREEN, YELLOW), 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 1 CASE AND THEY HAVE REQUESTED CREDIT. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323460 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES, 4 CLAMPS (RED, WHITE, GREEN, YELLOW), 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 3 CASES AND THEY HAVE REQUESTED CREDIT. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322609 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES, 4 CLAMPS (RED, WHITE, GREEN, YELLOW), 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 22322423 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES, 4 CLAMPS (RED, WHITE, GREEN, YELLOW), 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 3 CASES AND THEY HAVE REQUESTED CREDIT. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322249 ↗
• 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 WAS 1 CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635585 ↗
• MalfunctionMar 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES, 4 CLAMPS (RED, WHITE, GREEN, YELLOW), LUER LOCK THAT EXPERIENCED LEAKAGE. THIS IS 1 OF 2 REPORTS. THE REPORT STATED THAT THE DEVICE IS LEAKING. SAMPLE PHOTOS ARE PROVIDED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635435 ↗
• MalfunctionDec 31, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES, 4 CLAMPS (RED, WHITE, GREEN, YELLOW), LUER LOCK WHERE IT WAS REPORTED PRODUCT CRACKED-LINE LEAKING. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING PATIENT USE. 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 21049107 ↗
• MalfunctionDec 31, 2024Crack; Fluid/Blood Leak; Material Separation; Crack; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES, 4 CLAMPS (RED, WHITE, GREEN, YELLOW), LUER LOCK WHERE IT WAS REPORTED PRODUCT CRACKED-LINE LEAKING. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING PATIENT USE. 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 21049106 ↗
• MalfunctionDec 31, 2024Crack; Fluid/Blood Leak; Material Separation; Crack; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED 5.5" (14 CM) APPX 1.2 ML, SMALLBORE QUADFUSE EXT SET W/3 CLAVE¿, 3 CHECK VALVES, 4 CLAMPS (RED, WHITE, GREEN, YELLOW), LUER LOCK WHERE IT WAS REPORTED PRODUCT CRACKED-LINE LEAKING. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING PATIENT USE. 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 21049103 ↗

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-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-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-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-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-0189-2021 · Jul 6, 2020 · Terminated
  9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(0
• Z-0241-2021 · Jul 6, 2020 · Terminated
  6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)2501
• Z-0258-2021 · Jul 6, 2020 · Terminated
  112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case
• 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-0234-2021 · Jul 6, 2020 · Terminated
  47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01
• Z-0247-2021 · Jul 6, 2020 · Terminated
  7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravasc

…and 173 more.