Shiley 10DICRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 60884522005208), received between Apr 18, 2018 and Apr 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, DURING NORMAL PROCEDURE, THE DEVICE HAD A DIMENSIONAL ISSUE. IT WAS INDICATED THAT WHILE THE INNER CANNULA WAS BEING INTRODUCED INSIDE THE TRACHEOSTOMY TUBE, THEY HAD OBSERVED INNER CANNULA RESISTANCE. IT WAS STATED THAT THE INNER CANNULA AND TRACHEOSTOMY TUBE WERE COMPATIBLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7440689 ↗