DAR 350/5865ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521066908), received between Feb 10, 2025 and Apr 9, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE BREATHING SYSTEM CIRCUIT SET FAILED THE PERFORMED LEAK TEST. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835131 ↗
• MalfunctionApr 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE BREATHING SYSTEM CIRCUIT SET FAILED THE PERFORMED LEAK TEST. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835093 ↗
• MalfunctionJan 27, 2026Gas/Air Leak

  IT WAS REPORTED THAT A N AIR LEAK WAS DETECTED WHEN THE CIRCUIT WAS CONNECTED TO THE VENTILATOR ALONG WITH THE FILTER AND ADAPTOR PRIOR TO USE. THE ISSUE WAS RESOLVED AFTER THE CIRCUIT REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194046 ↗
• MalfunctionJan 27, 2026Gas/Air Leak

  IT WAS REPORTED THAT A N AIR LEAK WAS DETECTED WHEN THE CIRCUIT WAS CONNECTED TO THE VENTILATOR ALONG WITH THE FILTER AND ADAPTOR PRIOR TO USE. THE ISSUE WAS RESOLVED AFTER THE CIRCUIT REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193956 ↗
• MalfunctionMay 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, A LEAK TEST OF THE RESPIRATORY SYSTEM DETECTED A LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100431 ↗
• MalfunctionMay 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, A LEAK TEST OF THE RESPIRATORY SYSTEM DETECTED A LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100341 ↗
• MalfunctionFeb 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT PRIOR TO USAGE, THERE WAS AN AIR LEAK OBSERVED BUT UNDETERMINED FROM THE REPORTED BREATHING SYSTEM DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343452 ↗