DAR 5093600Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521784604), received between Jun 16, 2021 and Dec 19, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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.

• MalfunctionDec 19, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT ASYNCHRONY WAS OBSERVED ON THE VENTILATOR DURING CONNECTION OF THE PATIENT CIRCUIT, AND A LEAK WAS IDENTIFIED BY THE RESPIRATORY THERAPIST, WHO DETERMINED THAT THE LEAK ORIGINATED FROM THE PATIENT CIRCUIT. INSPECTION REVEALED A RUPTURE OR LEAK ON THE CIRCUIT TUBING NEAR THE CONNECTOR SITE. THE CIRCUIT WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23852088 ↗
• MalfunctionDec 16, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT ASYNCHRONY WAS OBSERVED ON THE VENTILATOR DURING CONNECTION OF THE PATIENT CIRCUIT, AND A LEAK WAS IDENTIFIED BY THE RESPIRATORY THERAPIST, WHO DETERMINED THAT THE LEAK ORIGINATED FROM THE PATIENT CIRCUIT. INSPECTION REVEALED A RUPTURE OR LEAK ON THE CIRCUIT TUBING NEAR THE CONNECTOR SITE. THE CIRCUIT WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824797 ↗
• MalfunctionDec 16, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT ASYNCHRONY WAS OBSERVED ON THE VENTILATOR DURING CONNECTION OF THE PATIENT CIRCUIT, AND A LEAK WAS IDENTIFIED BY THE RESPIRATORY THERAPIST, WHO DETERMINED THAT THE LEAK ORIGINATED FROM THE PATIENT CIRCUIT. INSPECTION REVEALED A RUPTURE OR LEAK ON THE CIRCUIT TUBING NEAR THE CONNECTOR SITE. THE CIRCUIT WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824784 ↗
• MalfunctionDec 16, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT ASYNCHRONY WAS OBSERVED ON THE VENTILATOR DURING CONNECTION OF THE PATIENT CIRCUIT, AND A LEAK WAS IDENTIFIED BY THE RESPIRATORY THERAPIST, WHO DETERMINED THAT THE LEAK ORIGINATED FROM THE PATIENT CIRCUIT. INSPECTION REVEALED A RUPTURE OR LEAK ON THE CIRCUIT TUBING NEAR THE CONNECTOR SITE. THE CIRCUIT WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824776 ↗
• MalfunctionJun 16, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD A HOLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011238 ↗