Medex 292004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688517173), received between Apr 12, 2019 and Sep 4, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2022Component Missing; Component Missing

  IT WAS REPORTED THE GREEN PRESSURE INDICATOR WAS MISSING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353696 ↗
• MalfunctionJun 3, 2021Gas/Air Leak; Gas/Air Leak

  INVESTIGATION COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935884 ↗
• InjuryApr 12, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL ENDOTRACHEAL TUBE WAS IN USE, PATIENT LOST LUNG RECRUITMENT AND OXYGEN SATURATION LEVELS DROPPED TO LOW 40S. A LEAK WAS NOTED AROUND THE CUFF, REQUIRING 3 ML OF AIR INTO THE CUFF TO STOP THE LEAK. IT WAS REPORTED PATIENT HAD SEVERE ARDS, REQUIRING 20 OF PEEP AND SATING OF MID 80S. IT WAS REPORTED THAT NO INJURY HAD OCCURRED TO PATIENT AS A RESULT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 8510854 ↗