ICU Medical B4020Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00887709008717), received between Sep 29, 2023 and Sep 10, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Backflow

  The event involved a extension set 3 Way High Flow Stoplock w/rotating luer reported that when a three-way stopcock was added to an existing and functional setup, venous reflux was observed in the tubing when IV infusions were restarted. After irrigation and verification of the circuit by 2 nurses, a second instance of venous reflux was noted. These 2 events resulted in significant hemodynamic instability in the patient, requiring minor resuscitation. There was a patient involvement and patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714497 ↗
• MalfunctionJan 24, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE THE CUSTOMER REPORTED THAT UNSPECIFIED SEDATION MEDICATION WAS BEING INFUSED WHEN THEY NOTICED BLOOD BACKING UP IN IV CATHETER AND LEAKING OUT THE STOPCOCK. THE CUSTOMER FLUSHED THE LINE AND NOTICED FLUSH WAS COMING OUT OF A SIDE SLIT ON THE STOPCOCK; MEDICATION WAS SEEPING OUT OF SIDE SLIT. THE CUSTOMER STATED THAT THE DEFECTIVE STOPCOCK CAUSED PATIENT TO BE UNDERDOSED, AND MINIMAL LOSS OF BLOOD TO THE PATIENT WITH THE BREAK IN SYSTEM. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173504 ↗
• MalfunctionNov 4, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE IT WAS STATED THAT "WHEN THE BD LEUR LOCK SYRINGE WAS ATTACHED TO THE STOPCOCK FOR PUSHING FLUIDS DURING A RESUSCITATION, THE BD SYRINGE STARTED LEAKING AND THEN SNAPPED OFF AT THE LUER CONNECTION." THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464441 ↗
• MalfunctionJun 19, 2025Leak/Splash; Leak/Splash

  THE EVENT INVOLVED A 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE PATIENT (IN THE INTENSTIVE CARE UNIT) WAS INTUBATED ON CVVHD (CONTINUOUS VENO-VENOUS HEMODIAFILTRATION), RECEIVING SEDATIVES VIA PA CATHETER PLACED IN CATH LAB. PATIENT BECAME EXTREMELY AGITATED, AND ATTEMPTING TO SELF-EXTUBATE AND REMOVE LINES. SEDATIVES WERE LEAKING ONTO BED AND THE STOPCOCK REPLACED WITH ONE FROM ICU. THE PATIENT WAS SAFELY SEDATED AGAIN. THE CUSTOMER REPORTED AND ADVERSE OUTCOME, BUT NO FURTHER INFORMATION WAS PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22294365 ↗
• InjuryJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE THE REPORTER STATED THAT THE PATIENT WAS ON HIGH-DOSE PRESSORS WHEN THE BLOOD PRESSURE SUDDENLY DROPPED TO 40¿S/20¿S. THEN THE PROVIDER CALLED TO ROOM, AND THEY CAME PREPARING TO CARDIOVERT AND POSSIBLY BEGIN CPR. IT WAS NOTED THAT MEDICATION WAS LEAKING ONTO BED. THEY REPLACED LEAKING STOPCOCK, AND BLOOD PRESSURE INCREASED TO 220¿S SYSTOLIC. THERE WAS ADVERSE EVENT AND UNKNOWN DELAY IN THERAPY REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 22290121 ↗
• MalfunctionJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE THE REPORTER STATED THAT THE PATIENT WAS RECEIVING BLOOD VIA CORDIS PLACED IN CATH LAB AND THERE WAS BLOOD LEAKING ONTO BED. THERE WAS UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290113 ↗
• MalfunctionOct 16, 2024Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT A STOPCOCK 3-WAY HIGH FLOW ROTATING LUER GENERATED A LEAK DURING PATIENT USE. THE REPORT STATED, "WHILE GIVING ADENOSINE WE HAD A MALFUNCTION WITH THE STOPCOCK. THE STOPCOCK YELLOW CLAMP WAS TURNED IN THE PROPER POSITION AND I WAS HOLDING PRESSURE AFTER INSTILLING THE ADENOSINE AND WHILE RN2 WAS PUSHING THE FLUSH, FLUID WAS SPRAYING OUT THE SIDE OF THE STOP COCK. THE IV WAS FLUSHING WELL AND SO WAS FLUID FROM THE STOP COCK FROM ALL PARTS. WE HAD THIS INCIDENT 2 TIMES UNTIL WE EVENTUALLY HAD TO START MOVING THE YELLOW TAB OVER TO THE MED PORT DURING THE INSTALLATION BUT SEEMS LIKE AN UNNECESSARY STEP AND AN UNEXPECTED OCCURENCE." THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467620 ↗
• MalfunctionAug 27, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER. THE CUSTOMER REPORTED THAT THE PATIENT'S PROPOFOL LINE CHANGED BY NIGHTSHIFT RN PRIOR TO LEAVING, SHORTLY AFTER WRITER NOTED PATIENT'S MAP DECREASING AND PATIENT SPONTANEOUSLY AWAKENING DESPITE NO CHANGE TO SEDATION INFUSION. UPON ASSESSMENT OF PATIENT, STOPCOCK WHERE PROPFOL INFUSING NOTED TO HAVE CRACKED AND LEAKING ALL MEDICATIONS AND SEDATION INTO BED, LINE ALSO BACKED UP WITH BLOOD. THE WRITER IMMEDIATELY PAUSED INFUSIONS AND CHANGED OUT BROKEN STOPCOCK AND RESUMED INFUSIONS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075728 ↗
• MalfunctionAug 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER W/ROTATING LUER CA/50 WHERE IT WAS REPORTED THE DEVICE LEAKED AND CAUSED A RADIOACTIVE SPILL. THE EVENT OCCURRED DURING INFUSION OF A RADIOACTIVE CARDIAC IMAGING TRACER AND WAS IN CONTACT WITH THE PATIENT / HEALTHCARE PROVIDER. THE SPILL DRIPPED ON THE GROUND AND CONTAMINATED A SHOE OF A HEALTHCARE WORKER. THE PATIENT WAS FINE AFTER THE INCIDENT. THE STOPCOCK LEAKED OUT OF THE MIDDLE TURNING LEVER HOLDER. THE STOP COCK WAS ATTACHED TO AN INTRAVENOUS (IV) TUBING. THE TEST WAS COMPLETED WITH THE FAULTY PRODUCT. THERE WAS NO HOLE, CUT, TEARS OR ANY DEFECT NOTED. THERE WAS A PATIENT INVOLVEMENT, HOWEVER, NO HARM OR ADVERSE EVENT. DUE TO THE SMALL RADIOACTIVE SPILL THAT OCCURRED, THERE WAS MORE EXPOSURE TO EVERYONE IN THE ROOM, MORE THAN IF THERE WAS NO SPILL.

  Patient problems: Chemical Exposure

  MAUDE report 19928494 ↗
• MalfunctionMar 21, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE STOP COCK HAD A HOLE IN THE PLASTIC, ALLOWING FOR MEDICATION TO ESCAPE THE CLOSED IV MED ADMINISTRATION SYSTEM. WHILE THIS OCCURRED, A SIGNIFICANT AMOUNT OF BLOOD BACKED OUT OF THE IV CATHETER THERAPY, AND WAS NOT GETTING THE SEDATIVE, AND AS A RESULT WOKE UP, POSING HARM TO PATIENT. IT WAS FURTHER STATED THAT THE PATIENT HAD MEDICATIONS INFUSING THROUGH A CENTRAL LINE LOCATED IN THE RIGHT IJ (INTERNAL JUGULAR). STOPCOCKS WERE IN PLACE BETWEEN EACH MEDICATION LINE THAT IS INFUSING. UPON ASSESSMENT, A STOPCOCK HAD A CRACK AND BLOOD STARTED TO BACK FLOW FROM THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948138 ↗
• MalfunctionOct 3, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER GENERATED A LEAK AT THE POINT OF CONNECTION FROM THE STOPCOCK TO THE INTRAVENOUS (IV) FLUID LINE. THIS IS ALSO WHERE CRACKS WERE SEEN. THERE WAS NO UNPROTECTED EXPOSURE TO THE PATIENT, HEALTHCARE PROFESSIONAL, OR ANY OTHER PERSON(S). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT HARM REPORTED. THIS IS REPORT TWO OF TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865595 ↗
• MalfunctionOct 3, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER GENERATED A LEAK AT THE POINT OF CONNECTION FROM THE STOPCOCK TO THE INTRAVENOUS (IV) FLUID LINE. THIS IS ALSO WHERE CRACKS WERE SEEN. THERE WAS NO UNPROTECTED EXPOSURE TO THE PATIENT, HEALTHCARE PROFESSIONAL, OR ANY OTHER PERSON(S). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT HARM REPORTED. THIS IS REPORT ONE OF TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865589 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER IN WHICH THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH STOPCOCK LEAKING IN THE NEONATAL INTENSIVE CARE UNIT (NICU).THE LEAK WAS HAPPENING AT THE POINT OF CONNECTION FROM THE STOPCOCK TO THE IV FLUID LINE. THERE WAS NO OBVIOUS DEFECT NOTED ON THE TUBING SET LIKE CRACKS OR BREAKS, AND NO UNPROTECTED EXPOSURE TO THE PATIENT, HEALTHCARE PROFESSIONAL OR ANY OTHER PERSON. THE PRODUCT WAS USED ON A PATIENT WHEN THE EVENT OCCURRED, HOWEVER, THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843154 ↗

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-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-0215-2021 · Jul 6, 2020 · Terminated
  29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case. UDI:(01)10840619082533(17)250101(30)50(10)4605138. The Intravascular Admi
• 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-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-0221-2021 · Jul 6, 2020 · Terminated
  83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. UDI:(01)10887709089508(17)250101(30)25(10)45
• 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-0255-2021 · Jul 6, 2020 · Terminated
  148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841. The Intrav
• Z-0262-2021 · Jul 6, 2020 · Terminated
  8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(17)250101(30)50(10)4605676. CLAVE Neutron i

…and 173 more.