ICU Medical B55005Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00887709010079), received between Mar 9, 2022 and Jan 28, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK VALVE, CLAMP, ROTATING LUER, 1 EXT WHERE IT WAS REPORTED THE MANIFOLD WAS LEAKING AT PROPOFOL SITE FOR A PATIENT UNDER SEDATION (SEDATION FOR ANTIEPILEPTIC REASONS). BEFORE THE REPORTED ISSUE, THE PATIENT WAS SEDATED AND INTUBATED DUE TO POST CODE BLUE. PATIENT HAD SEVERE MYOCLONIC SEIZURES AND WAS KEPT STABLE WITH SEDATION. DURING THE REPORTED ISSUE, THE PATIENT WAS STABLE WITH SEDATION. AFTER THE REPORTED ISSUE, THE PATIENT WAS STABLE AS THE NURSE NOTICED PRIOR TO ANY SEIZURES RESUMING. THE PATIENT WAS NOT HARMED; HOWEVER, IT WAS CONSIDERED NEAR MISS - HIGH RISK. THE DELAY IN THERAPY WAS THE PATIENT NOT RECEIVING THE PROPOFOL NEEDED TO CONTROL HER EPILEPTIC EVENTS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256721 ↗
• InjuryDec 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, REGARDING A 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE EXPERIENCED LEAKAGE THAT REQUIRED MEDICAL INTERVENTION TO ALLEVIATE DROP IN BLOOD PRESSURE. THE CUSTOMER REPORTED THAT THE MANIFOLD CONNECTION AT GREEN PORT SPONTANEOUSLY STARTED TO LEAK WHILE RUNNING VASOACTIVE MEDICATION (NOREPINEPHRINE) RESULTING IN DROP IN PATIENT'S SYSTOLIC BLOOD PRESSURE AND ADDITION OF OTHER VASOACTIVE MEDS; PHENYLEPHRINE INFUSION INITIATED. LEAK NOT IMMEDIATELY OBVIOUS AND DISCOVERED WITH REPOSITIONING 1 HOUR LATER. ADDITIONAL VASOACTIVE MEDICATION STOPPED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM REPORTED BUT THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023528 ↗
• MalfunctionSep 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK VALVE, CLAMP, ROTATING LUER, 1 EXT WHERE THE CUSTOMER REPORTED THAT A MANIFOLD LEAKED FROM THE GREEN PORT DURING USE. THE PATIENT HAD A CONTINUOUS FUROSEMIDE INFUSION IN WHICH THE NURSE NOTED BUBBLES OF FLUID AT THE TOP OF THE DEVICE LEAKING FROM THE GREEN PORT. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127256 ↗
• MalfunctionAug 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 14" (36 CM) EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK VALVE, CLAMP, ROTATING LUER, 1 EXT WHERE THE CUSTOMER REPORTED LEAKING, AT THE RED KNOB, DURING PATIENT INFUSION OF A CRITICAL DRUG INOTROPES THAT CAME INTO CONTACT WITH THE PATIENT AND HEALTHCARE PROVIDER. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT; THERE WAS WORK FLOW DISRUPTION AND A SPILL KIT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931623 ↗
• MalfunctionJul 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK VALVE, CLAMP, ROTATING LUER, 1 EXT WHERE IT WAS REPORTED INTRAVENOUS (IV) INFUSIONS ATTACHED TO MANIFOLD WAS LEAKING FLUID FROM BUTTONS OF THE MANIFOLD. INTERRUPTION OF CONTINUOUS IV MEDICATIONS COULD POTENTIALLY AFFECT PATIENT¿S HEART RATE, BLOOD PRESSURE, PAIN MANAGEMENT, AND SEDATION LEVELS. THE CAREGIVER CHANGED OUT LEAKING MANIFOLDS TO ADDRESS THE ISSUE. THE PRODUCT WAS USED ON A PATIENT AT THE TIME OF THE INCIDENT. NO PATIENT HARM OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT. THERE WAS A DELAY IN CRITICAL THERAPY WHEN THE PROBLEM WAS NOTED AS PATIENT WAS NOT RECEIVING FULL DOSE OF IV MEDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816322 ↗
• MalfunctionJul 17, 2024Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  THE EVENT INVOLVED A 14" (36 CM) EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK VALVE, CLAMP, ROTATING LUER, 1 EXT WHERE IT WAS REPORTED THAT BLOOD BACKED UP INTO THE MANIFOLD AND STARTED TO LEAK FROM THE GREEN PORT. TWO MEDICATIONS (DOBUTAMINE AND MILRINONE) WERE INFUSING INTO THE RED AND BLUE PORTS AT A TOTAL OF 5ML/HR. THE MAINTENANCE LINE WAS INFUSING AT 20ML/HR. DESPITE THIS 25ML/HR INFUSION, BLOOD BACKED UP FROM THE PA LINE VIP PORT INTO THE MANIFOLD AND STARTED TO LEAK FROM THE GREEN PORT. THE GREEN AND YELLOW PORTS WERE NOT BEING USED NOR WERE THEY CAPPED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760942 ↗
• MalfunctionJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 14" (36 CM) EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK VALVE, CLAMP, ROTATING LUER, 1 EXT WHERE IT WAS REPORTED THAT THE RED PORT OF 4-PORT MANIFOLD USED FOR CONTINUOUS INFUSION OF PROPOFOL WAS LEAKING. UPON ADMISSION TO THE CVICU THE RED PORT WAS NOTED TO BE VISIBLY LEAKING FROM THE TOP OF THE PORT. IT WAS ALSO STATED THERE WAS A RISK THAT THE PATIENT MAY NOT HAVE BEEN RECEIVING THE APPROPRIATE AMOUNT OF PROPOFOL. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO PATIENT HARM AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564104 ↗
• MalfunctionJun 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 14" (36 CM) EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK VALVE, CLAMP, ROTATING LUER, 1 EXT WHERE IT WAS REPORTED THAT THE BLOOD BACKED UP INTO THE MANIFOLD AND STARTED TO LEAK FROM THE GREEN PORT. WHEN THE LINE WAS FLUSHED TO THE PATIENT, THERE WAS NO LEAKING OF ANY OF THE PORTS. THE CONTINUOUS INFUSION WAS CHANGED TO A DIFFERENT PORT AND THERE WERE NO FURTHER ISSUES. THERE WAS PATIENT INVOLVEMENT HOWEVER, NO PATIENT HARM AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547183 ↗
• MalfunctionMay 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK VALVE, CLAMP, ROTATING LUER, 1 EXT GENERATED A LEAK DURING PATIENT USE. THE REPORT STATED THAT THE YELLOW PORT OF THE MANIFOLD EXTENSION SET LEAKED WHEN INFUSING PROPOFOL. THE COMPLAINT WAS NOTICED DURING USE; THE PRODUCT WAS CONTAMINATED DURING USE; ONLY ONE QUANTITY WAS AFFECTED; PROBLEM FREQUENCY: REOCCURRING. THE INCIDENT OCCURRED IN THE CVICU DEPARTMENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235759 ↗
• InjuryMar 9, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED IN AN INTENSIVE CARE UNIT (ICU) AND INVOLVED A 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK VALVE, CLAMP, ROTATING LUER, 1 EXT. IT WAS REPORTED THAT A CRACK/LEAK WAS OBSERVED ON THE DEVICE WHEN MULTIPLE PRESSORS AND SEDATIVES HAD BEEN INFUSING INTO THE CENTRAL LINE OF A PATIENT. IT WAS NOTED THAT THE PRODUCT WAS USED FOR LESS THAN SEVEN HOURS WHEN THE EVENT OCCURRED. THE PATIENT¿S BLOOD PRESSURE DECREASED DRASTICALLY, AND A PATIENT CODE RESULTED. COMPRESSIONS WERE PERFORMED, THE GANG BAR WAS REPLACED, AND THERAPY RESUMED. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM REPORTED.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 13715355 ↗

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-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-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-0222-2021 · Jul 6, 2020 · Terminated
  123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)4536733;(01)10887709085432(17)250101(30)25(10)4573641. The In
• Z-0236-2021 · Jul 6, 2020 · Terminated
  7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)1088770906
• 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-0225-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088501(17)250201(30)25(10)4733705.
• Z-0185-2021 · Jul 6, 2020 · Terminated
  5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.
• 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

…and 173 more.