Medex MX4343LMRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10351688507617), received between Jan 13, 2025 and Jan 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD A SPONTANEOUS DROP IN BLOOD PRESSURE AFTER THE STAFF MOVED THE HEAD OF BED UP TO 45 DEGREES. THE BLOOD PRESSURE DROPPED AS LOW AS 60/30 DESPITE INCREASED TITRATION OF VASOPRESSORS AND THEN RECOVERED WITH FLUID BOLUS AND PHENYLEPHRINE BOLUS. IT WAS NOTED AFTER ABOUT 15-20 MINUTES THAT THE PRESSOR INFUSIONS WERE NOT GOING INTO PATIENT'S CVC BECAUSE THE MANIFOLD HAD COME UNSCREWED FROM THE PORT. THIS WAS QUICKLY CLEANED AND REATTACHED AND PATIENT'S BLOOD PRESSURE RECOVERED. END OF MANIFOLD THAT SCREWS ON TO PORT OF INFUSION CATHETER SOMETIMES BECOMES LOOSE AND CAN COME APART. THERE HAVE BEEN A FEW INSTANCES OF THIS HAPPENING WITH THIS DEVICE ON THE UNIT. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203031 ↗
• MalfunctionJul 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT'S INFUSION WAS ONGOING FOR NOREPINEPHRINE 0.4 MCG/KG/MIN AND VASOPRESSIN 0.04 UNITS/MIN. PATIENT WAS RECEIVING BOLUS OF FLUIDS. LINES WERE CHECKED AND THE MULTI-PORT DEVICE/STOPCOCK MANIFOLD (3 PORTS) WAS LEAKING AT THE NEEDLELESS CONNECTION AT THE CENTRAL VENOUS ACCESS DEVICE (CVAD) WITH PRESSORS INFUSING; AND THE BED SHEET WAS NOTED TO BE SIGNIFICANTLY WET. LINES WERE CHANGED, AND THE PATIENT'S BLOOD PRESSURE WAS RESPONDING EFFECTIVELY TO PRESSORS. PRESSORS WERE STOPPED DUE TO BLOOD PRESSURE PARAMETERS. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440551 ↗
• MalfunctionApr 22, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSE AND RT WERE TURNING THE PATIENT AND NOTICED A POOL OF PROPOFOL AND FENTANYL UNDERNEATH THE PATIENT. ON FURTHER INSPECTION IT WAS FOUND THAT THE IV MANIFOLD HAD A CRACK NEAR THE CONNECTION. MANIFOLD CHANGED OUT AND PATIENT RECEIVED BOTH PROPOFOL AND FENTANYL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882265 ↗
• MalfunctionJan 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOP COCK MANIFOLD WAS FOUND TO BE LEAKING MEDICATION ON TO THE FLOOR. ALL CONNECTIONS WERE CHECKED DURING SAFETY CHECK AT THE START OF THE SHIFT. NO LOOSE CONNECTION OR CRACKS WERE FOUND IN THE MANIFOLD TO EXPLAIN THE LEAKAGE. THE ISSUE WAS RESOLVED BY REPLACING THE MANIFOLD. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143342 ↗