Shiley 86236 (UDI 10884521797284)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521797284), received between Mar 11, 2022 and Aug 9, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, DURING USE, THE MARKINGS OF THE ENDOTRACHEAL TUBE WORE OFF AFTER BEING TAPED A COUPLE OF TIMES. THE DEPTH AND THE EXACT PLACEMENT OF THE TUBE WERE NOT CONFIRMED. THE PATIENT HAD A SATUATION ISSUE AND WAS COUGHING AND WAS UNABLE TO MOVE THE TUBE AND RE-TAPE DUE TO A LACK OF MARKINGS. THE PATIENT HAD AN UNPLANNED EXTUBATION.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 19949991 ↗
• MalfunctionJul 8, 2024Disconnection; Disconnection

  ACCORDING TO THE REPORTER, DURING INSPECTION, IT WAS FOUND THAT BOTH OF THE ENDOTRACHEAL TUBES' 15MM CONNECTORS WERE SEPARATED FROM THE TUBES, AS SHOWN IN THE IMAGE ATTACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690618 ↗
• MalfunctionJul 5, 2024Disconnection; Disconnection

  ACCORDING TO THE REPORTER, DURING INSPECTION, IT WAS FOUND THAT BOTH OF THE ENDOTRACHEAL TUBES' 15MM CONNECTORS WERE SEPARATED FROM THE TUBES, AS SHOWN IN THE IMAGE ATTACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680690 ↗
• 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 19102629 ↗
• MalfunctionMar 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TIP OF THE DEVICE'S TUBE WAS CRACK AND DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13732155 ↗