ICU Medical B4018Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00887709008694), received between Apr 29, 2021 and Jun 20, 2025 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

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

  THE EVENT INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE IT WAS REPORTED WHILE USING THE 4-WAY STOPCOCK FOR A SALINE BUBBLE STUDY (FOR AN ECHOCARDIOGRAM) THE ITEM LEAKED, CAUSING SALINE AND BLOOD TO SPRAY. IT WAS NOTED THAT THE ENTIRE AMOUNT OF SALINE/BLOOD MIXTURE (9 CC) "SPRAYED" OVER THE PATIENT AND STAFF. THE STOPCOCK AND ALL SURROUNDING PIECES WERE WET. ADDITIONALLY, THERE WAS BLOOD VISIBLE IN THE AREA OF THE STOP COCK BETWEEN THE WHITE AND THE CLEAR PLASTIC. THERE WAS NO HOLE, TEARS OR ANY DEFECT WAS NOTED. ADDITIONALLY, THE EVENT OCCURRED MULTIPLE TIMES - SOME SMALL LEAKS AND 2 LARGE ONES. THEY HAD 2 INJECTIONS THROUGH THE STOPCOCK WITHOUT A PROBLEM; THEY DID NOT MOVE THE STOPCOCK AND ON THE THIRD INJECTION THAT THE SALINE SPRAYED OVER THE STAFF. NO HUMAN HARM. REPORTED. THIS REPORT CAPTURES 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297434 ↗
• MalfunctionAug 27, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER. THE REPORT STATED THAT THERE HAS A LEAKING AND CRACK IN PRODUCT. THE IMPACT OF THE PROBLEM IS SERIOUS. THE FREQUENCY OF PROBLEM WAS FIRST TIME, AND THE LOCATION OF SAMPLE WAS IN THEIR DEPARTMENT. THE CUSTOMER STATED THAT THE FAULT OCCURRED DURING INFUSION OR WHILE IN USE WITH PATIENT. THE LEAK¿S EXACT LOCATION ON TUBING WAS STOPCOCK TO STOPCOCK. THE INFUSING WAS FLUID AND MEDICATIONS, VASOPRESSORS. THE TUBING WAS REPLACED ONCE THE LEAK WAS IDENTIFIED. THERE WERE NO VISIBLE CRACKS, AND THE CONNECTION WAS GOOD, BUT IT WAS LEAKING ON THE BED. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081280 ↗
• MalfunctionAug 27, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE IT WAS REPORTED THAT THE LINES UNSCREW FROM THEM VERY EASILY AND WITH PRESSURE CAUSES THEM TO DISCONNECT. THE PRODUCT WAS USED ON A PATIENT AT THE TIME OF THE INCIDENT. THERE WAS NO DELAY IN THE CRITICAL THERAPY WHEN THE PROBLEM WAS NOTED. ADDITIONALLY, STAFF WERE ALMOST FINISHED WITH THE PROCEDURES WHEN THE ITEM FAILED. STAFF NOTED THAT WHEN THEY INITIALLY CONNECT TO THE STOPCOCK THE LINES DO NOT DISENGAGE. BUT ONCE THEY REMOVED THE LINE AND ATTACHED IT AGAIN, IT WOULD START TO DISENGAGE (UNSCREW) ON ITS OWN. DURING PATIENT USE, IT DID START TO LEAK WHEN APPLYING PRESSURE FROM A SYRINGE. BUT IF STAFF NOTICED IT NOT WORKING, THEY SWITCHED TO A NEW STOPCOCK. THERE WAS NO SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT, USER, OR OTHER, AND NO DEATH OF A PATIENT, USER, OR OTHER PERSON, AND NO POTENTIAL FOR DEATH OR SERIOUS DETERIORATION IN HEALTH OF A PATIENT, USER, OR OTHER PERSON THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT, AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078853 ↗
• MalfunctionAug 27, 2024Disconnection; Disconnection

  THE EVENT INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE IT WAS REPORTED THAT THE LINES UNSCREW FROM THEM VERY EASILY AND WITH PRESSURE CAUSES THEM TO DISCONNECT. THE PRODUCT WAS USED ON A PATIENT AT THE TIME OF THE INCIDENT. THERE WAS NO DELAY IN THE CRITICAL THERAPY WHEN THE PROBLEM WAS NOTED. ADDITIONALLY, STAFF WERE ALMOST FINISHED WITH THE PROCEDURES WHEN THE ITEM FAILED. STAFF NOTED THAT WHEN THEY INITIALLY CONNECT TO THE STOPCOCK THE LINES DO NOT DISENGAGE. BUT ONCE THEY REMOVED THE LINE AND ATTACHED IT AGAIN, IT WOULD START TO DISENGAGE (UNSCREW) ON ITS OWN. DURING PATIENT USE, IT DID START TO LEAK WHEN APPLYING PRESSURE FROM A SYRINGE. BUT IF STAFF NOTICED IT NOT WORKING, THEY SWITCHED TO A NEW STOPCOCK. HERE WAS NO SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT, USER, OR OTHER, AND NO DEATH OF A PATIENT, USER, OR OTHER PERSON, AND NO POTENTIAL FOR DEATH OR SERIOUS DETERIORATION IN HEALTH OF A PATIENT, USER, OR OTHER PERSON. HERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT, AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078817 ↗
• MalfunctionAug 27, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER AND OCCURRED ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT IN JUNE, THE LINES WOULD DISENGAGE VERY EASILY. THE ISSUE WITH THE LINES COMING OFF THE STOPCOCK COULD HAVE BEEN A RADIATION SAFETY ISSUE - SPILLS (SINCE THEY INJECT RADIOACTIVE SOLUTION THROUGH THE STOPCOCKS). IT WOULD HAVE POTENTIALLY CLOSED SOME OF OUR DEPARTMENT IF THE SPILL WAS LARGE ENOUGH OR RESULTED IN PERSONNEL CONTAMINATION. THERE WAS NO SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT, USER, OR OTHER, AND NO DEATH OF A PATIENT, USER, OR OTHER PERSON, AND NO POTENTIAL FOR DEATH OR SERIOUS DETERIORATION IN HEALTH OF A PATIENT, USER, OR OTHER PERSON. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT, AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077620 ↗
• InjuryAug 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER THAT WAS REPORTEDLY LEAKING NOREPINEPHRINE FROM THE STOPCOCK PLASTIC HUB, HOWEVER, THERE NO LEAKS FROM LEUR LOCK CONNECTION SITES. THE PATIENT WAS RECEIVING THIS IV MEDICATION TO MAINTAIN CEREBRAL PERFUSION PRESSURE (CPP) AND INTRACRANIAL PRESSURE (ICP) GOALS. THE PATIENT REPORTEDLY HAD A SUDDEN UNSPECIFIED DECREASE IN CPP, DECREASED BLOOD PRESSURE (BP), INCREASED ICP AND ALSO PRESENTED OXYGEN DESATURATION BECAUSE THE IV MEDICATION AMOUNT WAS LOWER THAN INTENDED. THE CUSTOMER STATED THAT THERE WAS MINIMAL, UNSPECIFIED HARM TO THE PATIENT.

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 19939353 ↗
• MalfunctionAug 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE IT WAS REPORTED A PATIENT'S ARTLINE MAP SLOWLY DROPPED FROM 80'S TO 70'S TO 60'S, NOREPINEPHRINE INFUSION INCREASED FROM 0.22MCG/KG/MIN TO 0.3 WITH NO EFFECT IN BLOOD PRESSURE. INFUSION INCREASED TO 0.5 AND MAP DROPPED TO 40'S, PT HAD A PULSE, PUSH LINE RATED INCREASED TO 50ML/HR, ART LINE ZEROED AND LEVELED, STOP COCK CONNECTIONS CHECKED AND NOTED TO FIND THE BEDSHEET WET. ON CLOSE INSPECTION THE STOPCOCK FOUND TO BE LEAKING OVER THE PILLOW AND BED, IMMEDIATELY CALLED CRN FOR ASSISTANCE AND STOPCOCK CHANGED AND NOREPINEPHRINE INCREASED TO 1MCG/KG/MIN BRIEFLY AND NOTED IMPROVEMENT IN BP AND MAP'S. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 19931642 ↗
• MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE IT WAS REPORTED THE STOPCOCK WAS LEAKING. NO OBVIOUS DAMAGE SEEN, AND CONNECTION WAS TIGHT. STOPCOCKS WERE CHANGED IMMEDIATELY. IT WAS REPORTED THAT THE LEAKING STARTED HOURS AFTER IT WAS INITIATED AND OCCURRED DURING A PROPOFOL AND FENTANYL INFUSION. PATIENT WOKE UP AND ALMOST PULLED OUT ENDOTRACHEAL TUBE, WAS RESTLESS, HAD TO RECEIVE A DOSE OF MIDAZOLAM WHILE STOPCOCK WAS REPLACED. THERE WAS PATIENT INVOLVED AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829239 ↗
• MalfunctionJul 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER GENERATED A LEAK DURING PATIENT USE. IT WAS REPORTED, ¿NOTED PATIENT WAKING UP AND NON-COMPLAINT VENTILATOR DESPITE INCREASING SEDATION TO MAX AMOUNT. THE NOTED LEAK FROM STOPCOCK TO STOPCOCK AT THE CONNECTION SITE AND PROPOFOL WAS LEAKING AND NOT BEING ADMINISTERED TO THE PATIENT. THE FREQUENCY OF THE PROBLEM WAS RECURRING, AND NO OTHER DEVICES WERE INVOLVED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19737157 ↗
• MalfunctionJul 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER. IT WAS REPORTED THAT THE STOPCOCKS STARTED TO LEAK DURING A PATIENT'S ADMINISTRATION OF AN UNSPECIFIED FLUID AND VASOPRESSOR MEDICATION. THE LEAK WAS REPORTEDLY ON THE TUBING AT 'STOPCOCK TO STOPCOCK' LOCATION. AFTER THE LEAK WAS IDENTIFIED, THE TUBING DEVICE WAS REPLACED. THERE WAS NO VISIBLE CRACKS, THE ORIGINAL CONNECTION WAS GOOD, HOWEVER, THE DEVICE WAS LEAKING ON THE BED. THERE WAS NO REPORT OF HUMAN HARM ASSOCIATED WITH THE COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707469 ↗
• MalfunctionJun 30, 2024Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  IT WAS REPORTED THAT A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER GENERATED A LEAK DURING PATIENT USE. AS PER REPORT, THE STOP COCK IS INTERMITTENTLY BLOCKED AND LEAKING AT DIFFERENT SIDE AT START OF USE; DURING INDUCTION PHASE WHEN IT IS AT A CRITICAL TIME. THE DEVICE IS AVAILABLE FOR INVESTIGATION. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19641168 ↗
• InjuryApr 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER. THE STOPCOCK OF THE DEVICE WAS REPORTEDLY LEAKING. THE PATIENT¿S MEAN ARTERIAL PRESSURE (MAP) DROPPED AND DID NOT INITIALLY RECOVER, EVEN WITH TITRATION OF NOREPINEPHRINE; BLOOD PRESSURE DROPPED TO 70/40S C MAP OF 40S. THE PATIENT¿S INFUSIONS WERE THEN ASSESSED AND THE STOPCOCK WAS IDENTIFIED TO BE LEAKING AT THAT TIME. THEY TRIED TO TIGHTEN THE STOPCOCK BUT IT WAS STILL LEAKING. THE STOPCOCK WAS QUICKLY CHANGED OUT AND THEN THE PATIENT¿S NON-INVASIVE BLOOD PRESSURE (NIBP) RECOVERED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 19177475 ↗
• MalfunctionApr 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE PRODUCT INVOLVED IS A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER IT WAS REPORTED THAT DURING AN INFUSION A LEAKED NOREPINEPHRINE. THE PATIENT DID RECEIVE THERAPY THAT WOULD NOT HAVE BEEN REQUIRED IF THE LEAK HAD BEEN IDENTIFIED. ACCORDING TO THE MEDICAL TEAM¿S ASSESSMENT THE NOREPINEPHRINE WAS INCREASING TO MAINTAIN AN APPROPRIATE BLOOD PRESSURE. THIS INFORMATION CAUSED THE MEDICAL TEAM TO BELIEVE THE PATIENT WAS SEPTIC AND REQUIRING AND INTRAVENOUS BOLUS, WHICH THE PATIENT RECEIVED. NOT IMMEDIATE HARM CAME TO THE PATIENT WITH THE INFUSION OF THE BOLUS WHICH WOULD HAVE BEEN IDENTIFIED BY VENTILATOR SUPPORT CHANGES, BUT THE PATIENT DID RECEIVE THERAPY THAT WAS NOT APPROPRIATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19056781 ↗
• MalfunctionJan 18, 2024Disconnection; Loose or Intermittent Connection; Disconnection; Loose or Intermittent Connection

  THE EVENT INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER WHERE IT WAS REPORTED STOPCOCK LUER LOCK ONLY THREADS 1-1.5 ROTATIONS, WITH CONTINUOUS MOVEMENT OF IV LINES, THE LUER LOCK LOOSENS ITSELF BECAUSE DISCONNECTED. THIS HAPPENED ON A CRITICAL ICU PATIENT ON ROUTE TO CT SCAN, LUER LOCK/STOPCOCK FOR INOTROPE LOOSENED AND DISCONNECTED BY ITSELF AND BLOOD PRESSURE STARTED TO CRASH. HAULTING ROUTE TO CT SCAN TO STABILIZE PATIENT, MULTIPLE PROFESSIONALS WITNESSED. FREQUENCY OF THE PROBLEM WAS RECURRING. IMPACT OF THE PROBLEM WAS SEVERE. THERE WAS PATIENT INVOLVEMENT AND THERE WAS PATIENT HARM. THE ADVERSE EVENT WAS LUER LOCK/STOPCOCK DISCONNECTED BY ITSELF AND BLOOD PRESSURE STARTED TO CRASH. HAULTING ROUTE TO CT SCAN TO STABILIZE PATIENT. THE MEDICATION INVOLVED WAS VASOPRESSOR. THERE WAS NO BLOOD LOSS OR BLEED BACK.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 18540324 ↗
• MalfunctionApr 29, 2021Connection Problem; Material Split, Cut or Torn; Connection Problem; Material Split, Cut or Torn

  THE EVENT INVOLVED A 4-WAY HIGH FLOW STOPCOCK W/ ROTATING LUER WHICH WAS USED TO INFUSE FENTANYL VERSED AND PRECEDEX DRIPS TO A CRITICALLY ILL CHILD. THE CONNECTION BETWEEN 2 OF THE STOPCOCKS WAS FOUND TO BE SPLIT IN HALF AND THE PATIENT DID NOT RECEIVE THE INFUSION FOR ABOUT ONE HOUR. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY, HOWEVER, THERE WAS NO PATIENT HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748333 ↗

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-0186-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)
• 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-0210-2021 · Jul 6, 2020 · Terminated
  13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)108
• Z-0200-2021 · Jul 6, 2020 · Terminated
  12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case. UDI: (01)10887709070100(17)250101(30)50(10)45727
• 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-0232-2021 · Jul 6, 2020 · Terminated
  58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460
• 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

…and 173 more.