Medex MX9311LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10351688504180), received between Oct 15, 2021 and May 15, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING WAS BROKEN AND CRACKED. UPON ASSESSMENT, THE PATIENT¿S BED WAS WET, AND THE TPN TUBING AT THE STOPCOCK SITE APPEARED CRACKED. THE CONTINUOUS TPN WAS STOPPED, AND THE PHYSICIAN WAS NOTIFIED. THE AFFECTED INDIVIDUAL WAS AN INPATIENT, INCLUDING AN OBSERVATION PATIENT, AND THE DEVICE WAS FOUND TO BE IN AN UNSAFE CONDITION. THERE WAS PATIENT INVOLVEMENT, BUT NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183463 ↗
• MalfunctionApr 20, 2026Crack; Fluid/Blood Leak

  IT WAS STATED THAT PROPOFOL WAS INFUSING DURING PATIENT TRANSPORT TO MRI, IT WAS FOUND THAT MEDICATION WAS ON THE BED LINENS AND THAT THE 3 WAY STOPCOCK WAS LEAKING. IT WAS NOTED THAT THE 3 WAY STOPCOCK WAS CRACKED. THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932714 ↗
• MalfunctionApr 20, 2026Crack; Fluid/Blood Leak

  IT WAS STATED THAT PROPOFOL WAS INFUSING DURING PATIENT TRANSPORT TO MRI, IT WAS FOUND THAT MEDICATION WAS ON THE BED LINENS AND THAT THE 3 WAY STOPCOCK WAS LEAKING. IT WAS NOTED THAT THE 3 WAY STOPCOCK WAS CRACKED. THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932678 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak

  IT WAS STATED THAT THE STOPCOCK WAS USED TO ADMINISTER MEDICATIONS, AND WHEN IT WAS TURNED, IT COMPLETELY CAME APART. IT WAS ATTACHED TO THE PATIENT¿S CENTRAL LINE AND IMMEDIATELY BEGAN BLEEDING BACK. THE LINE WAS QUICKLY CLAMPED; HOWEVER, THE SITUATION COULD HAVE BEEN CATASTROPHIC BECAUSE IT WAS UNDER THE DRAPE AND COULD HAVE GONE UNNOTICED. THE AFFECTED INDIVIDUAL WAS AN INPATIENT, INCLUDING AN OBSERVATION PATIENT. THE INCIDENT INVOLVED THE PATIENT, AND NO PATIENT HARM OCCURRED, AS THE ISSUE WAS ADDRESSED PROMPTLY AND NO MONITORING WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743484 ↗
• InjuryAug 30, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE STOPCOCK ATTACHED TO THE PROXIMAL PORT OF A CENTRAL VENOUS CATHETER CVC BEING USED FOR CENTRAL VENOUS PRESSURE CVP MONITORING BECAME DISCONNECTED WHILE THE PATIENT WAS TRANSFERRED TO THE COMMODE RESULTING IN THE PATIENT PASSING OUT AND REQUIRING INTUBATION. THERE WAS NO LOSS OF PULSE HOWEVER, THE PATIENT WAS LATER DIAGNOSED WITH A STROKE AS A RESULT OF A VENOUS AIR EMBOLUS. THE ORIGINAL INTENDED PROCEDURE WAS THE CENTRAL VENOUS PRESSURE MONITORING POST CARDIAC SURGERY.

  Patient problems: Loss of consciousness; Stroke/CVA

  MAUDE report 17655949 ↗
• MalfunctionOct 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A PINHOLE IN THE PRODUCT MAKING IV FLUIDS LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643313 ↗