DAR 444SP02014 (UDI 10884521822894)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521822894), received between Aug 4, 2025 and Jan 21, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Gas/Air Leak

  IT WAS REPORTED THAT LEAKAGE OCCURRED ON THE WHITE ATTACHMENT PIECE TO THE ENDOTRACHEAL TUBE OF THE SUCTION CATHETER, AND NO AIR WAS ENTERING THE LUNGS. THE PROBLEM WAS SOLVED BY CHANGING THE SUCTION SYSTEM. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24140301 ↗
• InjuryAug 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE INSTALLATION OF A CLOSED SUCTION SYSTEM SEVERAL LEAKS WERE OBSERVED ON THE FAN SIDE DEVICE. THE VENTILATOR WAS SET TO DELIVER A VOLUME OF 420, BUT ONLY 160 WAS ACTUALLY DELIVERED. THE PATIENT EXPERIENCED INITIAL INSTABILITY AND A SLIGHT WORSENING OF DESATURATION, WHICH WAS QUICKLY CORRECTED. TWO NURSES AND A PHYSIOTHERAPIST ATTEMPTED TO TIGHTEN THE SYSTEM AND REINFORCE THE TUBING, BUT DUE TO THE PATIENT'S INSTABILITY, THE SYSTEM WAS REPLACED WITH A TRACHEOSTOMY. THE SYSTEM WAS THEN REPLACED WITH A STANDARD CATHETER MOUNT PRODUCT, WHICH RESTORED NORMAL VENTILATION VOLUMES.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22705315 ↗