Medex MX4810Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 50351688507004), received between Sep 9, 2022 and Mar 20, 2025 — classified as 15 malfunctions.

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

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2025Fluid/Blood Leak; Inflation Problem; Material Separation; Gas/Air Leak; Fluid/Blood Leak; Inflation Problem; Material Separation; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AIR LEAKAGE FROM THE CONNECTING LINE WITH THE INFLATION BULB. THE EVENT OCCURRED DURING PRE-TEST, AND IT HAPPENED AT THE HOSPITAL. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21658030 ↗
• MalfunctionMar 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CONNECTING LINE WITH THE INFLATION BULB WAS LEAKING DURING PRE-TEST. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21622606 ↗
• MalfunctionMar 17, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE INFLATION BULB WAS DISCONNECTED FROM THE STOPCOCK DURING PRE-TEST. THERE WAS NO PATIENT HARM PR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21622358 ↗
• MalfunctionDec 26, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LOT NUMBER INDICATED ON THE OUTSIDE OF THE PRODUCT BOX DOES NOT MATCH THE LOT NUMBER ON THE ITEMS INSIDE. THE EVENT OCCURRED UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020009 ↗
• MalfunctionAug 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WITH THE DEVICE THERE WAS A DISCREPANCY BETWEEN THE LOT NUMBER PRINTED ON THE BOX. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096408 ↗
• MalfunctionMar 13, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE CONNECTION BETWEEN THE HOSE AND SQUEEZE BULB WAS LOOSE, EVEN AFTER CHANGING THE SQUEEZE BULB. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18897672 ↗
• MalfunctionJun 23, 2023Failure to Zero; Failure to Zero

  IT WAS REPORTED THAT THE PRODUCT WOULD NOT REACH TO "ZERO". PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17194909 ↗
• MalfunctionSep 10, 2022Increase in Pressure; Pressure Problem; Increase in Pressure; Pressure Problem

  IT WAS REPORTED THAT DEVICE IS READING VERY HIGH PRESSURE, ANOTHER DEVICE IS READING VERY LOW. DEVICES FAILED DURING TESTING STRAIGHT OUT OF THE BOX, NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397523 ↗
• MalfunctionSep 10, 2022Increase in Pressure; Pressure Problem; Increase in Pressure; Pressure Problem

  IT WAS REPORTED THAT DEVICE IS READING VERY HIGH PRESSURE, ANOTHER DEVICE IS READING VERY LOW. DEVICES FAILED DURING TESTING STRAIGHT OUT OF THE BOX, NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397522 ↗
• MalfunctionSep 9, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE INFLATING BULB WAS BREAKING OFF THE STOP AND CANNOT PUT IT BACK ON WHICH CAUSED THE BAG TO LEAK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396917 ↗
• MalfunctionSep 9, 2022Break; Break

  IT WAS REPORTED THAT THE BAGS WERE BREAKING VERY QUICKLY AND THE INFLATING BULB WAS BREAKING OFF THE STOP AND COULD NOT PUT IT BACK ON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392983 ↗
• MalfunctionSep 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAK ON THE HOSE THAT IS ATTACHED TO THE BULB TO INFLATE THE BAG OCCURRED 4 TIMES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392396 ↗
• MalfunctionSep 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK ON THE HOSE THAT IS ATTACHED TO THE BULB TO INFLATE THE BAG. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392376 ↗
• MalfunctionSep 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK ON THE HOSE THAT IS ATTACHED TO THE BULB TO INFLATE THE BAG. NO PATIENT INJURY REPORTED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392244 ↗
• MalfunctionSep 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK ON THE HOSE THAT IS ATTACHED TO THE BULB TO INFLATE THE BAG. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392236 ↗