Shiley 86237 (UDI 10884521797291)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521797291), received between Feb 7, 2022 and Apr 13, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (1 report).

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 13, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THE NUMBERS OR MARKING HAD WORN OFF, EVEN ABOVE WHERE THE ENDOTRACHEAL TUBE WAS TAPED DURING USE. THE TUBE WAS RETAPED MULTIPLE TIMES UNTIL IT WAS DECIDED TO BE REPLACED ELECTIVELY.

  Patient problems: Insufficient Information

  MAUDE report 19102628 ↗
• InjuryFeb 28, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE SIX DIFFERENT ENDOTRACHEAL TUBES WITH UNIDENTIFIED AFFECTED QUANTITY HAD A GENERAL COMPLAINT ABOUT QUALITY AND TEXTURE THAT CAUSED TRAUMA TO THE NASAL PASSAGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18803877 ↗
• MalfunctionFeb 7, 2022Disconnection; Material Integrity Problem; Disconnection; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S 15MM CONNECTOR WAS NOT FULLY INSERTED TO THE TUBE AND CAME OUT WHEN THE PHYSICIAN REMOVED THE OXYGEN (O2) BAG TO SUCTION IN A DROWNING PATIENT. THE PATIENT WAS EXTUBATED AND USED ANOTHER TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 13472139 ↗