DAR 444SP02014 (UDI 20884522035207)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20884522035207), received between Jan 10, 2024 and Feb 23, 2025 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (10 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE UNIT HAD A DAMAGE THAT CAUSED LEAKAGE FROM THE SUCTION CONTROL VALVE AND THE ROTATING VALVE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442433 ↗
• MalfunctionDec 10, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS AIR LEAKAGE DURING SUCTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20889082 ↗
• InjurySep 2, 2024Connection Problem; Gas/Air Leak; Connection Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THERE WAS AN AIR LEAK OBSERVED BETWEEN TUBE AND VENTILATOR HOSES. A CRACKED ON THE WHITE TIP (SIDE OF THE RINGED CONNECTOR THAT GOES TO THE VENTILATOR HOSES) WAS ALSO FOUND. THE PATIENT HAD DESATURATION WITH HYPOXIA.

  Patient problems: Hypoxia; Low Oxygen Saturation

  MAUDE report 20122291 ↗
• InjuryAug 25, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE PATIENT DESATURATED WITH HYPOXIA AS AIR LEAKAGE NOISE BETWEEN THE INTUBATION PROBE AND RESPIRATOR HOSES WAS OBSERVED. THE SUCTION CATHETER WAS REPLACED AND FOUND A CRACKED WHITE TIP FROM THE SIDE OF THE RING FITTING THAT GOES TO THE PIPES OF THE RESPIRATOR.

  Patient problems: Hypoxia; Low Oxygen Saturation

  MAUDE report 20061056 ↗
• MalfunctionJul 12, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THERE WAS LEAKAGE ON THE VENTILATOR OF 30% AND AIR FLOW WAS AUDIBLE AFTER SYSTEM CHANGED. IT WAS FOUND THAT THE CLOSED SUCTION HAD A HOLE IN THE DISTAL BRANCH AT THE POINT OF CONNECTION TO THE VENTILATOR. THE SUCTION WAS REPLACED AND THE LEAKAGE WAS 0-3%. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19732596 ↗
• InjuryMar 25, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THERE WAS AIR LEAK IN THE CLOSED SUCTION SYSTEM. THE PATIENT DESATURATED AND HAD TO BE MANUALLY VENTILATED DURING TROUBLESHOOTING AND REPLACEMENT OF THE SUCTION SYSTEM.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18975704 ↗
• InjuryMar 5, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THERE WAS LEAKAGE IN THE CONNECTION BETWEEN THE SUCTION SYSTEM AND THE SWIVEL CONNECTOR DURING USE. THE PATIENT'S SATURATION DROPPED. THE SUCTION SYSTEM WAS REPLACED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18839521 ↗
• MalfunctionMar 1, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AN AIR LEAK WAS HEARD IN THE INTUBATION TUBE. OBSERVATION OF THE DEVICE REVEALED THAT THE CLOSED SYSTEM WAS BROKEN ON THE RESPIRATOR SIDE. THE SYSTEM WAS CHANGED IMMEDIATELY AND FIVE MINUTES AFTER FITTING THE NEW CLOSED SYSTEM, THE SAME PROBLEM WAS NOTED WITH A LEAK. WHEN THE CLOSED SYSTEM WAS REPLACED WITH A HYPOXEMIC CONNECTOR, THE CLOSED SYSTEM BROKE, CRUMBLING INTO THE VENTILATOR CIRCUIT AND MAKING IT IMPOSSIBLE TO RECONNECT THE PATIENT AND VENTILATE. THE DOCTOR HAD TO INTERVENE URGENTLY, AND THE PATIENT WAS VENTILATED USING A BAVU (SELF-FILLING BALLOON WITH ONE-WAY VALVE). THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18817948 ↗
• InjuryFeb 13, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD A 50% AIR LEAK IN THE SUCTION SYSTEM WHICH CAUSED A DECREASE IN THE SATURATION OF THE PATIENT FOR A SHORT TIME. THE SUCTION SYSTEM WAS REPLACED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18700193 ↗
• InjuryJan 10, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT'S SATURATION SUDDENLY DROPPED FOR NO IMMEDIATE REASON, AND THE VENTILATOR SHOWED 28% LEAKAGE. THE ANESTHESIOLOGIST DECIDED TO REMOVE THE CLOSED SUCTION SYSTEM, THEN THE LEAK WAS 0%. A COMPLETELY NEW END SYSTEM WAS USED, WHICH RESULTED IN 50% LEAKAGE. THE CLOSED SUCTION SYSTEM WAS COMPLETELY REMOVED, AND THE LEAKAGE DROPPED TO 0%. THE PRODUCT USE WAS STOPPED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18487297 ↗