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ICU Medical 011-CS25Recalls & reported problems

Icu Medical, Inc. · Check Valve with Male/Female Luer Lock · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
21
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00840619006075), received between Dec 30, 2022 and Jun 22, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 1 reportsMay 2024: 5 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 3 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fluid/Blood Leak17
  • Crack5
  • No Flow2
  • Insufficient Device Problem Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions15
  • Hemorrhage/Blood Loss/Bleeding4
  • Adult Respiratory Distress Syndrome2
  • Awareness During Anesthesia2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Exposure to Body Fluids1

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 22, 2026Fluid/Blood Leak

    AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK WHERE IT WAS REPORTED THAT DURING THE PLACEMENT OF THE VALVE ONTO THE PATIENT, AFTER SOME TIME BLOOD CAME OUT OF THE VALVE, ON THE PATIENT'S HAND. NO PROFOUND CUTS, HOLES OR INCONSISTENCIES IN THE VALVE, AND THE PROBLEM OCCURRED IN THE PAST TWO WEEKS AGO INCLUDING SEVERAL VALVES. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN HARM REPORTED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 25575937 ↗
  • MalfunctionApr 11, 2026Crack

    EVENT OCCURRED REGARDING A CHECK VALVE WHERE THE COMPLAINT WAS NOTIFIED TO A REGULATORY BODY WITH NOTIFICATION NUMBER (B)(4). IT WAS STATED THAT THEY SUCCESSFULLY INSERTED A LONG PERIPHERAL CATHETER AND ATTACHED AN ANTI-REFLUX VALVE (TO PREVENT OBSTRUCTION) WITH SECUREPORTIV GLUE (TO REDUCE THE RISK OF ACCIDENTAL REMOVAL). A FEW MINUTES LATER, THE NURSING STAFF NOTIFIED THEM THAT THE VALVE HAD BROKEN AND WAS SUBSEQUENTLY REPLACED. AS A PREVENTIVE MEASURE, THE GLUE IS NO LONGER USED IN LONG PERIPHERAL LINES SINCE IN OTHER PRODUCTS THERE IS NO PROBLEM BECAUSE THE VALVE IS FURTHER AWAY FROM THE GLUE. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24846274 ↗
  • MalfunctionApr 11, 2026Fluid/Blood Leak

    EVENT OCCURRED REGARDING A CHECK VALVE WITH MALE/FEMALE LUER LOCK, WHERE IT WAS REPORTED THAT PATIENT: EGL, AGE: 56, MALE, WEIGHT: 80 KG HAD LEAKING NOTED DURING PATIENT ROUNDS. LEAK SIGNIFICANT ENOUGH TO WET THE BED. RECURRENCE OF THE EVENT. DEVICE WAS REPLACED. DATE OF INSERTION: ON (B)(6) 2026. CURRENT PATIENT STATUS: NO IMMEDIATE CONSEQUENCES OBSERVED. THE ISSUE WAS REPORTED TO ANSM ¿ NATIONAL FRENCH REGULATORY AGENCY. THERE WAS REPORTED PATIENT INVOLVEMENT. THIS COMPLAINT IS RELATED TO (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24845981 ↗
  • MalfunctionMar 16, 2026Fluid/Blood Leak

    THE EVENT INVOLVED AN ANTI-REFLUX VALVE (CHECK VALVE WITH MALE/FEMALE LUER LOCK) LEAK WHEN IN USE WITH A CENTRAL VENOUS CATHETER (CVC). THIS CAUSED ALL THE PATIENT'S (UNSPECIFIED) SEDATION MEDICATIONS TO LEAK ON TO THE BED. THE PATIENT WAS INTUBATED, SEDATED, AND UNDER MUSCLE RELAXANTS, IN THE PRONE POSITION BECAUSE SHE WAS IN SEVERE RESPIRATORY DISTRESS. SUDDENLY, SHE BEGAN TO RAISE HER HEAD. THE CLINICIAN REACTED IMMEDIATELY BY SECURING HER AND NOTIFYING THE DOCTOR. ALL THE TUBING WAS CHANGED AS A PRECAUTION FOR THIS INSTANCE. THE PATIENT WAS IN DANGER. SHE WAS IMPROPERLY SEDATED, RESULTING IN UNCONTROLLED RESPIRATORY DISTRESS. ACTIONS TAKEN AT THE HEALTHCARE FACILITY FOR PATIENT MANAGEMENT: DUTY PHYSICIAN AND MANAGEMENT WERE NOTIFIED. THIS REPORT CAPTURES SECOND OF TWO OCCURRENCES FOR THE PATIENT.

    Patient problems: Adult Respiratory Distress Syndrome

    MAUDE report 24603187 ↗
  • MalfunctionMar 16, 2026Fluid/Blood Leak

    THE EVENT INVOLVED AN ANTI-REFLUX VALVE (CHECK VALVE WITH MALE/FEMALE LUER LOCK) LEAK WHEN IN USE WITH A CENTRAL VENOUS CATHETER (CVC). THIS CAUSED ALL THE PATIENT'S (UNSPECIFIED) SEDATION MEDICATIONS TO LEAK ON TO THE BED. THE PATIENT WAS INTUBATED, SEDATED, AND UNDER MUSCLE RELAXANTS, IN THE PRONE POSITION BECAUSE SHE WAS IN SEVERE RESPIRATORY DISTRESS. SUDDENLY, SHE BEGAN TO RAISE HER HEAD. THE CLINICIAN REACTED IMMEDIATELY BY SECURING HER AND NOTIFYING THE DOCTOR. ALL THE TUBING WAS CHANGED AS A PRECAUTION FOR THIS INSTANCE. THE PATIENT WAS IN DANGER. SHE WAS IMPROPERLY SEDATED, RESULTING IN UNCONTROLLED RESPIRATORY DISTRESS. ACTIONS TAKEN AT THE HEALTHCARE FACILITY FOR PATIENT MANAGEMENT: DUTY PHYSICIAN AND MANAGEMENT WERE NOTIFIED. THIS REPORT CAPTURES FIRST OF TWO OCCURRENCES FOR THE PATIENT.

    Patient problems: Adult Respiratory Distress Syndrome

    MAUDE report 24603180 ↗
  • MalfunctionMar 11, 2026Crack; Fluid/Blood Leak

    THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A CHECK VALVE WITH MALE/FEMALE LUER LOCK. A NURSE REPORTED A CRACK AND LEAK AT THE LEVEL OF THE ANTI-REFLUX VALVE WAS A VERY RECURRING PROBLEM WITH THIS PRODUCT (APPROXIMATELY ONCE A MONTH PER NURSE). THE CUSTOMER STATED THAT UNFORTUNATELY, DETAILS ON EACH INCIDENT (DATE, PATIENT INVOLVED, MEDICATIONS USED CANNOT BE RETRIEVED. THE REPORTS WERE NOT FILED BY THE DEPARTMENT. IT WAS THE RECURRENCE OF THE PROBLEM THAT LED TO A MEDICAL REPORT BEING FILED BY TECHNICAL NURSE OF THE INTENSIVE CARE UNIT. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24576022 ↗
  • MalfunctionFeb 27, 2026Crack; Fluid/Blood Leak

    THE EVENT INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK, AND IT WAS REPORTED THAT CRACK AND LEAK AT THE LEVEL OF THE ANTI-REFLUX VALVE DURING THE INFUSION. THERE WAS A LOSS OF PRODUCT. PROBABLY, SOME AIR CAME INTO CONTACT WITH THE PATIENT, BUT THERE WERE NO EMBOLISM OR NEUROLOGICAL CONSEQUENCES. THE NURSE SAW THE PRODUCT SPILL ONTO THE FLOOR. THE LEAK WAS CLEANED ACCORDING TO THE FACILITY'S PROTOCOL. THERE WAS PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24466442 ↗
  • MalfunctionFeb 17, 2026Fluid/Blood Leak

    A COMPLAINT WAS RECEIVED REGARDING A CHECK VALVE WITH MALE/FEMALE LUER LOCK IN WHICH IT WAS REPORTED THAT A LEAK WAS FOUND AT THE CHECK-VALVE DURING PATIENT USE. THERE WERE NO CLINICAL CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24370287 ↗
  • MalfunctionDec 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

    A LEAKAGE PROBLEM DURING PATIENT USE WITH A SPIROS WAS REPORTED WHEN USING A CHECK VALVE WITH MALE/FEMALE LUER LOCK. THE NON-RETURN VALVE WAS NOT WORKING. ONCE THE CONTRAST AGENT INJECTION WAS COMPLETED, BLOOD LEAKED ALL OVER THE PATIENT AND THE "SCAN" (NER). OTHER CONSEQUENCE: THERE WAS SURFACE CONTAMINATION. MEASURES TAKEN: SURFACE CLEANING. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Patient problems: Exposure to Body Fluids; Hemorrhage/Blood Loss/Bleeding

    MAUDE report 23783963 ↗
  • MalfunctionNov 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    THE EVENT INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK WHERE THE CUSTOMER DID NOT STATE A SPECIFIC ISSUE WITH THE DEVICE BUT DID PROVIDE A PHOTO SHOWING THE PATIENT HAD BLOOD ON HER HANDS WHILE IT WAS INJECTED USING THE PRODUCT - POTENTIAL LEAK. THERE WAS NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23453952 ↗
  • MalfunctionNov 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

    A COMPLAINT WAS RECEIVED REGARDING A CHECK VALVE WITH MALE/FEMALE LUER LOCK THAT EXPERIENCED LEAKAGE. THE FOLLOWING ISSUE WAS REPORTED BY THE CUSTOMER: ¿ AFTER INSERTING AND WASHING WITH SALINE, BLOOD REFLUX IS NOTED¿. THE PRODUCT IS AVAILABLE FOR EVALUATION. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT IS ¿UNKNOWN¿. THERE WAS YES , PATIENT INVOLVEMENT, A 19 YEARS OLD PATIENT, NO ADVERSE EVENT / HUMAN HARM. IN CLARIFICATION TO THE ABOVE DESCRIPTION , THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT IS "AFTER INSERTING AND WASHING WITH SALINE". THIS EVENT LEAD TO A DELAY IN THE START OF THE INTERVENTION, NO MEDICAL INTERVENTION NECESSARY FOLLOWING THIS EVENT, THIS EVENT WAS REPORTED BY THE COLLABORATOR WHO USED IT ,THE INFUSION WAS NOT STARTED WHEN THE PROBLEM OCCUR, THE PROGRAMMING ENTERED FOR THE INFUSION WAS DRUGS FOR MAINTENANCE SEDATION AND BALANCED ELECTROLYTICS , THE TUBING WAS REPLACED , ONLY THE VALVE HAVE BEEN REPLACED ,THE BLOOD LOSS OR REFLUX WAS NOT CONSIDERED CLINICALLY SIGNIFICANT, THE PATIENT'S CONDITION BEFORE AND AFTER THE EVENT WAS STABLE. IN CLARIFICATION, THE CUSTOMER CONFIRMED THAT ¿THERE WAS BLOOD LEAKING FROM THE CAP¿.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20735175 ↗
  • MalfunctionMay 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK WHERE IT WAS REPORTED BY THE CUSTOMER: ¿ANTI-REFLUX CAP POSITIONED WITH CONSTANT BLOOD LEAKAGE FROM THE CAP¿. THE DEVICE WAS AT FIRST USE AND THE CUSTOMER HAS ALSO STATED THAT THERE WERE NO CLINICAL CONSEQUENCES. THERE WAS PATIENT INVOLVEMENT, AGE 45 YEARS, HOWEVER NO ADVERSE EVENT OR HUMAN HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19392245 ↗
  • MalfunctionMay 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK WHERE THE CUSTOMER REPORTED THAT THE ANTI-REFLUX CAP POSITIONED WITH CONSTANT BLOOD LEAKAGE FROM THE CAP. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT / HUMAN HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19391552 ↗
  • MalfunctionMay 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE EVENT WAS A DELAY IN STARTING SURGICAL PROCEDURE, THE SUPERVISION WAS NECESSARY FOLLOWING THIS EVENT. THE CUSTOMER BECAME AWARE OF THIS EVENT AS IT WAS REPORTED BY COLLABORATORS. THE PROBLEM OCCURRED WITH THE PROCEDURE IN PROGRESS, ESTIMATED TIME OF APPROXIMATELY 30 MINUTES ONWARDS. THE PROGRAMMING ENTERED FOR THE INFUSION WAS INSERTION OF THE NEEDLE AND DEVICE AND ALMOST IMMEDIATE INFUSION. THE INFUSED THERAPY WAS HYDRATING ELECTROLYTES AND DRUGS FOR ANESTHETIC INDUCTION, NO CHEMOTHERAPY. THE INFUSION THERAPIES AND DEVICE WERE REPLACED. THE BLOOD LOSS OR BACKFLOW WERE NOT SIGNIFICANT DUE TO EARLY INTERCEPTION. THE PATIENT'S CONDITION BEFORE AND AFTER THE EVENT WAS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19367123 ↗
  • MalfunctionMay 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

    THE COMPLAINT/EVENT INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK. IT WAS REPORTED THAT THE ANTI-REFLUX CAP POSITION HAD CONSTANT BLOOD LEAKAGE FROM THE CAP AT THE FIRST USE. THERE WERE NO CLINICAL CONSEQUENCES AS A RESULT OF THIS COMPLAINT/EVENT.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

    MAUDE report 19317028 ↗
  • MalfunctionMay 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

    THE COMPLAINT/EVENT INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK. IT WAS REPORTED THAT THE ANTI-REFLUX CAP POSITION HAD CONSTANT BLOOD LEAKAGE FROM THE CAP AT THE FIRST USE. THERE WERE NO CLINICAL CONSEQUENCES AS A RESULT OF THIS COMPLAINT/EVENT.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

    MAUDE report 19282156 ↗
  • MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK, WHERE IT WAS REPORTED IN THE INFUSION LINE, BLOOD RETURNS THROUGH THE NON-RETURN VALVE. THE EVENT OCCURRED IN THE ANESTHESIA OPERATING ROOM WHEN THE PRODUCT WAS PLACED ON THE INFUSION LINE. THE VALVE WAS CHANGED. THE CUSTOMER STATED THERE WAS NON CLINICALLY SIGNIFICANT BLOOD LOSS. THERE WAS A DELAY IN THERAPY DUE TO THE TIME TO CHANGE VALVE AND BANDAGE. THE THERAPY WAS COMPLETED. THERE WAS NO DRUG ADMINISTERED, BUT CONTRAST AGENT. THE DOCTOR HAD SOME BLOOD ON HIS HANDS. THERE WAS NO MEDICAL INTERVENTION NEEDED, JUST HAND WASHING. THE LEAK DID NOT COME INTO CONTACT WITH THE PATIENT. THE LEAK WAS CLEANED UP ACCORDING TO FACILITY PROTOCOL WITH NO SPECIFIC KIT. THE PATIENT¿S CONDITION BEFORE, DURING AND AFTER THE INCIDENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT RECEIVED THE FULL INTENDED DOSE AFTER CHANGING THE CONSUMABLE. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19043314 ↗
  • MalfunctionMar 12, 2024No Flow; No Flow

    THE EVENT INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK WHERE IT WAS REPORTED BY THE CUSTOMER THE CHECK VALVE WAS NONFUNCTIONAL. THE INFUSED PRODUCT DOES NOT PASS, THE SYRINGE MUST BE PUSHED HARD. VERIFICATION OF THE CATHETER ON THE PATIENT, WHICH IS FUNCTIONAL. THE PATIENT COULD HAVE BEEN REINFUSED IF THE REPORTER HAD NOT TESTED THE CATHETER. THE VALVE WAS REMOVED AND DISCARDED. THE INCIDENT HAPPENED AT THE INTERVENTIONAL PREPARATION ROOM. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT IS DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO REPORT OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18886719 ↗
  • MalfunctionMar 8, 2024No Flow; No Flow

    THE EVENT INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK WHERE IT WAS REPORTED THAT THE VALVE IS WORKING DURING RINSING USING A SYRINGE, BUT DURING THE ADMINISTRATION OF PRODUCTS BY GRAVITY, THE VALVE REMAINS CLOSED, AND THE PRODUCT DOES NOT PASS. THE DEVICE WAS CONNECTED TO THE PATIENT AT THE TIME OF THE EVENT. THE PATIENT HEALTH¿S CONDITION DID NOT CHANGE, AND NO ONE WAS HARMED. THERE WERE NO VISIBLE SIGNS OF DEFECTS, MALFUNCTION OR PROBLEMS WITH THE DEVICE PRIOR TO USE. THERE WAS A DELAY DUE TO THE TIME FOR CHANGING THE ADMINISTRATION SET.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18864336 ↗
  • InjuryMar 16, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

    THE EVENT INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK WHERE IT WAS REPORTED ON THE NEUROSURGICAL INTENSIVE CARE UNIT, DURING A ROUND, A PATIENT WAS FOUND REACTIVE TO THE MEDICAL CARE, HYPERTENSIVE AND DISCONNECTED FROM THE RESPIRATOR. THE PATIENT SHOULD HAVE BEEN SEDATED. THE MEDICAL CARE TEAM OBSERVED THAT THE CHECK-VALVE WAS CRACKED AND THAT THERE WAS A FLOW OF LIQUID, AS HYPNOVEL, SUFENTANYL AND PROPOFOL WERE FLOWING ON THIS LINE. THIS RESULTED IN UNWANTED SUPPRESSION OF SEDATION, REBOUND OF INTRACRANIAL HYPERTENSION WITH RISK OF CEREBRAL DAMAGES, EVEN DEATH FOR THIS PATIENT. THE VALVE WAS THEN CHANGED. THERE WAS PATIENT INVOLVMENT AND ADVERSE EVENT. TWO USED DEVICES WERE RETURNED FOR INVESTIGATION AND ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATING BOTH THESE DEVICES WERE USED ON THE SAME PATIENT. THIS CAPTURES THE SECOND OF TWO OCCURRENCES.

    Patient problems: Awareness During Anesthesia

    MAUDE report 16552885 ↗
  • InjuryDec 30, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

    THE EVENT INVOLVED A CHECK VALVE WITH MALE/FEMALE LUER LOCK WHERE IT WAS REPORTED ON THE NEUROSURGICAL INTENSIVE CARE UNIT, DURING A ROUND, A PATIENT WAS FOUND REACTIVE TO THE MEDICAL CARE, HYPERTENSIVE AND DISCONNECTED FROM THE RESPIRATOR. THE PATIENT SHOULD HAVE BEEN SEDATED. THE MEDICAL CARE TEAM OBSERVED THAT THE CHECK-VALVE WAS CRACKED AND THAT THERE WAS A FLOW OF LIQUID, AS HYPNOVEL, SUFENTANYL AND PROPOFOL WERE FLOWING ON THIS LINE. THIS RESULTED IN UNWANTED SUPPRESSION OF SEDATION, REBOUND OF INTRACRANIAL HYPERTENSION WITH RISK OF CEREBRAL DAMAGES, EVEN DEATH FOR THIS PATIENT. THE VALVE WAS THEN CHANGED. THERE WAS PATIENT INVOLVEMENT AND ADVERSE EVENT.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Awareness During Anesthesia

    MAUDE report 16078357 ↗

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-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-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-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-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-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-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
  • 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-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-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-0188-2021 · Jul 6, 2020 · Terminated
    10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri-Connector, NanoClave T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouche

…and 173 more.

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Sources and updates

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