DAR 444S02608Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884522032810), received between Mar 24, 2025 and Mar 24, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE ENDOTRACHEAL ASPIRATION PHASE, SUDDENLY THE SECURING PART OF THE BREATHING SYSTEM SUCTION COVER WAS RELEASED, LOSING THE POSITIVE AIRWAY PRESSURE OF THE PATIENT; THE PRESSURE WAS IMMEDIATELY RESTORED BY THE OPERATOR CLOSING THE CIRCUIT WITH HIS HAND. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT HARM. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE SLEEVE DETACHED FROM THE SUCTION VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678178 ↗