Shiley 8DICRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 60884522005321), received between Aug 29, 2018 and May 6, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 6, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THERE WAS INSERTION OF A SIZE 8 INNER CANNULA IN A PATIENT WITH A SIZE 10 CANNULA. THE SIZE OF THE CANNULA WAS NOT RECOGNIZABLE ON THE CANNULA AND THE COLOR-CODED SIZE DISTINCTIONS ON THE PACKAGING AND THE INNER CANNULAS WERE NOT CLEAR. THE VENTILATOR WAS ADJUSTED SO THAT THE RESISTANCE COMPENSATED FOR THE NARROWEST POINT SINCE THE INNER CANNULA HAD A DIFFERENT DIAMETER THAN THE OUTER CANNULA. THE PATIENT TENDED TO "GET WORSE AIR" BUT NO SERIOUS CONSEQUENCES AROSE AND THE PATIENT WAS CONSISTENTLY STABLE. THE PATIENT HAD BEEN WEANING FROM THE VENTILATOR FOR ALMOST 40 DAYS AFTER A COVID INFECTION.

  Patient problems: Dyspnea

  MAUDE report 14311272 ↗
• MalfunctionNov 11, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS FLAT INSTEAD OF BEVELED OR TAPERED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801370 ↗
• InjuryAug 29, 2018Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE UNIT'S INNER CANNULA HAD A PIECE OF ROUND PLASTIC IN IT THAT WAS BLOCKING IT. THE PLASTIC IS CONNECTED IN THE TUBE AND WON'T COME OUT WITHOUT FORCE. THE PATIENT WAS RECANNULATED.

  Patient problems: Extubate

  MAUDE report 7828312 ↗