DAR 444SP02012 (UDI 10884521822887)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521822887), received between Sep 10, 2024 and Mar 12, 2026 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A ROUTINE SYSTEM CHANGE INVOLVING THE CLOSE SUCTION CIRCUIT, A PATIENT EXPERIENCED A DROP IN PERIPHERAL OXYGEN SATURATION DUE TO EXISTING SECRETIONS IN THE LUNGS. AN ATTEMPT WAS MADE TO SUCTION THE SECRETIONS ENDOTRACHEALLY, BUT SUCTION COULD NOT BE GENERATED BECAUSE THE BLUE SUCTION VALVE BUTTON WAS NOT FUNCTIONING. THE PERIPHERAL OXYGEN SATURATION CONTINUED TO FALL. PRE-OXYGENATION WAS PERFORMED, AND SECRETIONS WERE SUBSEQUENTLY REMOVED USING CONVENTIONAL STERILE SUCTIONING, AFTER WHICH OXYGEN SATURATION RETURNED TO NORMAL LEVELS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24583294 ↗
• MalfunctionJan 8, 2026Use of Device Problem

  IT WAS REPORTED THAT THE BREATHING SUCTION SYSTEM HAD A LEAK OCCURRED DURING PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007472 ↗
• MalfunctionNov 7, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE BREATHING SYSTEM SUCTION HAD A LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629462 ↗
• MalfunctionSep 23, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, AN AIR LEAK WAS CONFIRMED FROM THE VENTILATOR WAVEFORM AND WAS DETECTED IN THE SERPENTINE TUBE PART OF DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20286443 ↗
• MalfunctionSep 10, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE GAS FROM THE VENTILATOR WAS LEAKING FROM THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180484 ↗