Medex MX4805Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 50351688507011), received between Sep 9, 2022 and Mar 19, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Gas/Air 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE INFLATION BULB WAS DISCONNECTED FROM THE STOPCOCK. THE EVENT OCCURRED DURING PRE-TEST AND IT HAPPENED AT THE HOSPITAL. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21648981 ↗
• MalfunctionMar 19, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE INFLATION BULB WAS DISCONNECTED FROM THE STOPCOCK. THE EVENT OCCURRED 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 21648206 ↗
• MalfunctionJan 14, 2025Inflation Problem; Gas/Air Leak; Unintended Deflation; Inflation Problem; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO INFLATE PRESSURE INTO THE CUFF. THE PRESSURE GAUZE DOES NOT SHOW PRESSURE READING DUE TO A LEAK. A SECOND DEVICE WAS USED AND THE PRESSURE DECREASED AFTER BLOWING THE AIR FOR JUST A FEW MINUTES. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THE ISSUE WAS RESOLVED BY USING A NEW ONE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. TOTAL 2 DEVICES WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150012 ↗
• MalfunctionNov 20, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE WAS A DISCREPANCY BETWEEN THE LOT NUMBERS PRINTED ON THE LABELS AND THOSE ON THE ACTUAL PRODUCTS. THE LOT NUMBER ON THE BOX WAS 6015735 AND THE LOT NUMBER ON THE PRODUCT WAS 4262848. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20739758 ↗
• MalfunctionJun 2, 2023Fracture; Gas/Air Leak; Fracture; Gas/Air Leak

  PER ANVISA NOTIFICATION: DURING THE DEVELOPMENT OF THEIR ACTIVITIES IT WAS REPORTED THAT A HEALTH PROFESSIONAL OBSERVED AIR LEAKAGE FROM THE FAUCET CONNECTION AND WHEN REMOVING IT, THERE WERE CRACKS AND/OR BROKEN PARTS. THE PATIENT WAS IN ICU TREATMENT. NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED BY EMAIL ON (B)(6) 2023, REPORTING THAT THIS LOT IS NO LONGER AVAILABLE IN STOCK.

  Patient problems: Insufficient Information

  MAUDE report 17054864 ↗
• MalfunctionJun 2, 2023Fracture; Gas/Air Leak; Fracture; Gas/Air Leak

  PER ANVISA NOTIFICATION: DURING THE DEVELOPMENT OF THEIR ACTIVITIES IT WAS REPORTED THAT A HEALTH PROFESSIONAL OBSERVED AIR LEAKAGE FROM THE FAUCET CONNECTION AND WHEN REMOVING IT, THERE WERE CRACKS AND/OR BROKEN PARTS. THE PATIENT WAS IN ICU TREATMENT. NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED BY EMAIL ON (B)(6) 2023, REPORTING THAT THIS LOT IS NO LONGER AVAILABLE IN STOCK.

  Patient problems: Insufficient Information

  MAUDE report 17054826 ↗
• MalfunctionSep 20, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE BAG WILL INFLATE, HOWEVER DOES NOT RETAIN PRESSURE, EMPTIES GRADUALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454982 ↗
• MalfunctionSep 12, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PRESSURE GAUGE CANNOT SHOW EXACT PRESSURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402048 ↗
• MalfunctionSep 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PRODUCT LEAKED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392988 ↗