Medex MX43860Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10351688507532), received between Feb 23, 2024 and Mar 3, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Disconnection” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Disconnection

  IT WAS REPORTED THAT THE TUBING GOT DISCONNECTED FROM THE PATIENT ARTERIAL LINE WHILE WORKING WITH THE PATIENT. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT HOSPITAL. IT DID NOT LEAD TO HARM, BUT THE ARTERIAL LINE HAD TO BE REMOVED, AND PATIENT HAD MODERATE AMOUNT OF BLEEDING NOTED FROM THE DISLODGEMENT. THERE WAS AN ONGOING MONITORING OF THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503009 ↗
• MalfunctionOct 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THEY ARE CONTINUING TO HAVE ISSUES WITH ARTERIAL LINE EXTENSION TUBING DISCONNECTIONS. THEY WERE EASILY ABLE TO DISCONNECT THE TWO PIECES, AND THEY ARE USED ON PRESSURIZED ARTERIAL LINES WHERE PATIENTS CAN LOSE LARGE VOLUMES OF BLOOD IF NOT CAUGHT IN TIME. THERE IS PATIENT INVOLVEMENT AS IT WAS USED ON PATIENTS WITH PRESSURIZED ARTERIAL LINES. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430070 ↗
• MalfunctionSep 18, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT WHILE THE PATIENT WAS INFUSING CRITICAL MEDICATIONS INTO LINE, THE PATIENT TURNED, AND THE LINE DISCONNECTED FROM STOP COCK. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084770 ↗
• MalfunctionMay 22, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PLASTIC TUBING THAT GOES INTO THE STOPCOCK EASILY COMES OFF. REPORTER STATED THAT THERE WERE INSTANCES THAT THEY HAD CHANGED OUT 3 DEVICES AND SOME INSTANCES WHEN THEY THREW THE J-LOOP AWAY. THERE WAS PATIENT INVOLVEMENT BUT IT'S UNKNOWN IF PATIENT WAS INJURED/HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070641 ↗
• MalfunctionMay 22, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PLASTIC TUBING THAT GOES INTO THE STOPCOCK EASILY COMES OFF. REPORTER STATED THAT THERE WERE INSTANCES THAT THEY HAD CHANGED OUT 3 DEVICES AND SOME INSTANCES WHEN THEY THREW THE J-LOOP AWAY. THERE WAS PATIENT INVOLVEMENT BUT IT'S UNKNOWN IF PATIENT WAS INJURED/HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070631 ↗
• MalfunctionMay 21, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT EXTENSION TUBING WAS ATTACHED TO A NEEDLELESS CONNECTOR ON ONE END AND TO A MANIFOLD WITH TWO ONGOING MEDICATIONS, HEPARIN AND PRECEDEX, ON THE OTHER END. THE NURSE TURNED THE PATIENT AND SAW THAT THE EXTENSION TUBING, CONNECTED TO THE STOPCOCK, HAD DISCONNECTED OR "POPPED OFF." A LARGE PUDDLE OF LIQUID WAS FOUND ON THE PATIENT'S BED, AND IT IS UNCLEAR HOW LONG THE PATIENT HAD BEEN WITHOUT MEDICATION. THERE WAS NO MEDICAL INTERVENTION AND PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066240 ↗
• MalfunctionMar 6, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THEY HAD MULTIPLE INSTANCES OF THE EXTENSION WITH STOPCOCK GETTING DISCONNECTED AT THE CONNECTION WHERE THE STOPCOCK FUSED WITH THE EXTENSION PIECE. THERE WERE UNKNOWN PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536808 ↗
• MalfunctionDec 27, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE ARTERIAL LINE DISCONNECTED AT 4-WAY STOPCOCK. THE EVENT OCCURRED DURING USE. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029175 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE HAD BONDING ISSUES; BONDING COMING OFF. THE PATIENTS' ARTERIAL LINES WERE LEAKING BLOOD. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533156 ↗
• MalfunctionOct 22, 2024Break; Break

  IT WAS REPORTED THAT THE EXTENSION TUBING BROKE OFF AT THE STOPCOCK CONNECTION. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507898 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FOUR-WAY STOPCOCK EXTENSION UTILIZED WITH ARTERIAL LINES WERE SPONTANEOUSLY SEPARATING WHERE THE TUBING MEETS THE STOPCOCK. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297773 ↗
• MalfunctionApr 17, 2024Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT THE PRODUCT WAS CONNECTED TO AN ARTERIAL LINE TUBING AND WAS BEING USED ON A PATIENT. THE EXTENSION TUBING BROKE OFF AT THE STOPCOCK CONNECTION. THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF PATIENT HAD HARM OR AN ADVERSE EVENT OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 19126218 ↗
• MalfunctionFeb 23, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE STOPCOCK SEPARATED AT THE TUBING CONNECTION DURING USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773031 ↗