Shiley 96380Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 40884521157485), received between Aug 23, 2018 and Aug 23, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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. 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.

• MalfunctionAug 23, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD LEAKS UPON INTUBATION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 7809198 ↗
• InjuryAug 23, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THREE TUBES HAD LEAKS UPON INTUBATION. THE CUSTOMER REPORTED THAT INTUBATION USED A GLIDESCOPE AND WAS NOT DIFFICULT.

  Patient problems: Extubate

  MAUDE report 7809142 ↗
• InjuryAug 23, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THREE TUBES HAD LEAKS UPON INTUBATION. THE CUSTOMER REPORTED THAT INTUBATION USED A GLIDSCOPE AND WAS NOT DIFFICULT.

  Patient problems: Extubate

  MAUDE report 7809110 ↗