ICU Medical MC100Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 00887709037151), received between Jul 13, 2017 and Sep 17, 2026 — classified as 2 injuries, 141 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (100 reports).

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 25 most recent of 143 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Fluid/Blood Leak

  A reported incident involving a MicroClave Clear Neutral Connector involved blood being observed at the junction of the stopper following sample collection. The blood was clearly identifiable, and it was reported that the stopper was not airtight and exhibited leakage through its mechanism.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806663 ↗
• MalfunctionSep 7, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50656377 ↗
• MalfunctionSep 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50655761 ↗
• MalfunctionSep 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652336 ↗
• MalfunctionSep 7, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50651097 ↗
• MalfunctionSep 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650773 ↗
• MalfunctionAug 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175841 ↗
• MalfunctionJun 24, 2026Fluid/Blood Leak

  A REPORTED INCIDENT INVOLVING A MICROCLAVE CLEAR CONNECTOR LEAKAGE WAS OBSERVED AT THE CONNECTION SITE. THERE THERAPY CONTINUED WITHOUT DELAY. THERE WAS PATIENT INVOLVEMENT WITH NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25614220 ↗
• MalfunctionJun 24, 2026Fluid/Blood Leak

  A REPORTED INCIDENT INVOLVING A MICROCLAVE CLEAR CONNECTOR LEAKED AT THE DISTAL END OF A BD SYRINGE SET WITH A PRESSURE SENSING DISC. LEAKAGE WAS OBSERVED AT THE THREADED CONNECTION BETWEEN THE CLAVE AND THE SET. THE TUBING WAS REPLACED PROMPTLY, AND THERAPY CONTINUED WITHOUT DELAY. THERE WAS PATIENT INVOLVEMENT WITH NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25614159 ↗
• MalfunctionJun 24, 2026Fluid/Blood Leak

  A REPORTED INCIDENT INVOLVING A MICROCLAVE CLEAR CONNECTOR LEAKED AT THE DISTAL END OF A BD SYRINGE SET WITH A PRESSURE SENSING DISC. LEAKAGE WAS OBSERVED AT THE THREADED CONNECTION BETWEEN THE CLAVE AND THE SET. THE TUBING WAS REPLACED PROMPTLY, AND THERAPY CONTINUED WITHOUT DELAY. THERE WAS PATIENT INVOLVEMENT WITH NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25614092 ↗
• MalfunctionJun 12, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A MICROCLAVE CLEAR NEUTRAL CONNECTOR THAT LEAK AT THE CONNECTION BETWEEN THERE INFUSION SET LUER HUB AND TWO NEEDLELESS INJECTION CAPS AND THEIR INFUSION SET LUER HUB WAS TESTED USING A FEMALE ISO LUER TAPER GAUGE AND FOUND TO BE WITHIN SPECIFICATION HOWEVER THE TWO ICU NEEDLELESS INJECTION CAPS MICROCLAVE CONNECTOR WAS TESTED WITH A MALE ISO LUER TAPER GAUGE AND APPEARED TO BE AT THE EDGE OF THE SPECIFICATION. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485736 ↗
• MalfunctionMay 19, 2026Tear, Rip or Hole in Device Packaging

  EVENT OCCURRED REGARDING A MICROCLAVE CLEAR NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT A LEFT FOREARM PERIPHERAL INTRAVENOUS (PIV) LINE WAS NOTED TO HAVE BLOOD PRESENT WITHIN THE T-CONNECTOR. THE PIV WAS FLUSHED, AND SALINE WAS OBSERVED DISCHARGING FROM THE DISTAL END OF THE T-CONNECTOR BELOW THE MICROCLAVE T CONNECTOR JUNCTION. A SMALL TEAR WAS NOTED AT THE JUNCTION. THE T-CONNECTOR WAS REMOVED AND REPLACED WITH A NEW T-CONNECTOR. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO PATIENT HARM PER THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216606 ↗
• MalfunctionMay 11, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING A MICROCLAVE CLEAR NEUTRAL CONNECTOR IN WHICH IT WAS REPORTED THAT WHILE PERFORMING A STERILE LAB DRAW, THE PATIENT¿S CAP BECAME COMPLETELY FILLED WITH BLOOD. THE REGISTERED NURSE ATTEMPTED TO FLUSH THE CAP MULTIPLE TIMES; THE LINE FLUSHED WITHOUT RESISTANCE. HOWEVER, THE BLOOD WITHIN THE CAP COULD NOT BE CLEARED. AS A RESULT, THE REGISTERED NURSE REPLACED THE CAP. THERE IS PATIENT INVOLVEMENT, BUT THE HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142906 ↗
• MalfunctionApr 24, 2026Fluid/Blood Leak

  AN EVENT INVOLVED A MICROCLAVE CLEAR NEUTRAL CONNECTOR WITH ITEM NUMBER MC100 AND UNKNOWN LOT NUMBER. IT WAS REPORTED THAT MICROCLAVE WAS ATTACHED TO THE FUSED EXTENSION PIECE (MC3302) OF THE ¿PERIPHERALLY INSERTED CENTRAL CATHETER (PICC LINE)¿ LINE NOTED TO BE BACKUP/FILLING WITH FLUID. PHOTO OF THE DEFECTIVE ITEM WAS PROVIDED. THE EVENT OCCURRED IN USE FOR PATIENT INFUSION VIA CENTRAL LINE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988927 ↗
• MalfunctionApr 3, 2026Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS PATIENT INVOLVEMENT. HARM WAS NO ASSOCIATED WITH EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775164 ↗
• MalfunctionMar 13, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON UNSPECIFIED DATE IN (B)(6) 2026 INVOLVING A MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR. IT WAS REPORTED THAT A CLAVE WAS LEAKING VERSED. IT WAS REPORTED THAT THE PATIENT WAS ON MULTIPLE IV DRIPS. ADDITIONALLY, PER BEDSIDE RN, THE CLAVE FOUND LEAKING, PATIENT WET, DRIPS NOT INFUSING. THE EVENT OCCURRED IN THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596130 ↗
• MalfunctionMar 13, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON UNSPECIFIED DATE IN (B)(6) 2026, INVOLVING A MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR. IT WAS REPORTED THAT A CLAVE WAS LEAKING CALCIUM CHLORIDE. IT WAS REPORTED THAT THE PATIENT WAS ON MULTIPLE IV DRIPS. ADDITIONALLY, PER BEDSIDE RN, THE CLAVE FOUND LEAKING, PATIENT WET, DRIPS NOT INFUSING. THE EVENT OCCURRED IN THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596105 ↗
• MalfunctionMar 12, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON UNSPECIFIED DATE IN (B)(6) 2026, INVOLVING A MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR. IT WAS REPORTED THAT A CLAVE WAS LEAKING FENTANYL. IT WAS REPORTED THAT THE PATIENT WAS ON MULTIPLE IV DRIPS. ADDITIONALLY, PER BEDSIDE RN, THE CLAVE FOUND LEAKING, PATIENT WET, DRIPS NOT INFUSING. THE EVENT OCCURRED IN THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587448 ↗
• MalfunctionMar 11, 2026Fluid/Blood Leak

  MEDSUN UF/IMPORTER REPORT # (B)(4) WAS RECEIVED WITH REGARDS TO A MICROCLAVE CLEAR NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT A CLAVE WAS LEAKING DEXMEDETOMIDINE. IT WAS REPORTED THAT THE PATIENT WAS ON MULTIPLE IV DRIPS. ADDITIONALLY, PER BEDSIDE RN, THE CLAVE FOUND LEAKING, PATIENT WET, DRIPS NOT INFUSING. THE EVENT OCCURRED IN THE HOSPITAL. THE COMMON DEVICE NAME IS SET, ADMINISTRATION, INTRAVASCULAR. THE PATIENT WAS A 6-YEAR-OLD MALE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571022 ↗
• MalfunctionMar 11, 2026Fluid/Blood Leak

  MEDSUN UF/IMPORTER REPORT # (B)(4) WAS RECEIVED WITH REGARDS TO A MICROCLAVE CLEAR NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT A CLAVE WAS LEAKING DOPAMINE. IT WAS REPORTED THAT THE PATIENT WAS ON MULTIPLE IV DRIPS. ADDITIONALLY, PER BEDSIDE RN, THE CLAVE FOUND LEAKING, PATIENT WET, DRIPS NOT INFUSING. THE EVENT OCCURRED IN THE HOSPITAL. THE COMMON DEVICE NAME IS SET, ADMINISTRATION, INTRAVASCULAR. THE PATIENT WAS A 6-YEAR-OLD MALE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570639 ↗
• MalfunctionMar 11, 2026Fluid/Blood Leak

  MEDSUN UF/IMPORTER REPORT # (B)(4). WAS RECEIVED WITH REGARDS TO A MICROCLAVE CLEAR NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT A CLAVE WAS LEAKING EPI. IT WAS REPORTED THAT THE PATIENT WAS ON MULTIPLE IV DRIPS. ADDITIONALLY, PER BEDSIDE RN, THE CLAVE FOUND LEAKING, PATIENT WET, DRIPS NOT INFUSING. THE EVENT OCCURRED IN THE HOSPITAL. THE COMMON DEVICE NAME IS SET, ADMINISTRATION, INTRAVASCULAR. THE PATIENT WAS A 6-YEAR-OLD MALE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570378 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A MICROCLAVE CLEAR NEUTRAL CONNECTOR, AND IT WAS REPORTED THAT PATIENT WAS SEDATED ON THE RADIATION TABLE WHEN IT WAS NOTED THAT THE PORT THAT WAS HOOKED UP TO THE SYRINGE PUMP WITH PROPOFOL WAS LEAKING ON THE PATIENT AND RUNNING DOWN HIS CHEST. IT WAS NOTICED THAT THE CAP AT THE END OF THE PORT WAS LEAKING OUT THE SIDE OF THE CAP. PATIENT WAS GETTING READY TO RECEIVE RADIATION TREATMENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362984 ↗
• MalfunctionFeb 9, 2026Break; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING MICROCLAVE CLEAR NEUTRAL CONNECTOR IN WHICH IT WAS REPORTED THAT THE REGISTERED NURSE (RN) WAS GIVING PAIN MEDS, WENT TO FLUSH PORT, AND THE FLUSH LEAKED OUT THE SIDE OF THE CHANGEABLE CAP. THE RN CLAMPED CAP, AND THEN REPLACED THE CAP. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293828 ↗
• MalfunctionFeb 4, 2026No Flow

  MEDSUN UF/IMPORTER REPORT # (B)(4) WAS RECEIVED REGARDING AN EVENT THAT OCCURRED ON AN UNSPECIFIED DATE IN DECEMBER 2025. A MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR REPORTEDLY WAS A "DEAD ENDER" AND FLUID DOESN'T ALWAYS FLOW THROUGH IT. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260694 ↗
• MalfunctionJan 14, 2026Device Contamination with Chemical or Other Material

  THE EVENT INVOLVED A MICROCLAVE® CLEAR NEUTRAL CONNECTOR WHERE IT WAS REPORTED THE REGISTERED NURSE (RN) OPENED THE NEEDLELESS CONNECTOR AND FOUND IT HAD SEVERAL SMALL BLACK SPECS INSIDE OF THE ITEM. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073380 ↗