Shiley 86442Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30884522005689), received between Aug 29, 2018 and Apr 9, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE SIZE 3 HAD A PUNCTURED CUFF AND A CUFF LEAK OCCURRED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832326 ↗
• InjuryJul 3, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT'S CUFF WOULD NOT STAY INFLATED. THE PATIENT WAS RE-INTUBATED. THE PATIENT IS IN STABLE CONDITION AND UNDERGONE RETINAL LASER TO EYE FOR RETINOPATHY OF PREMATURITY. THE OPERATIVE COURSE WAS UNEVENTFUL AND THE PATIENT WAS EXTUBATED WITHOUT INCIDENT AND TAKEN TO THE RECOVERY ROOM.

  Patient problems: Extubate

  MAUDE report 8761388 ↗
• MalfunctionAug 29, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE¿S CUFF HAD BREAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7828243 ↗