Shiley 4DICRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 60884522005246), received between Dec 13, 2017 and May 16, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2022Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT HAD TROUBLE BREATHING AND DISCOVERED 50% OBSTRUCTION OF TRACH INNER CANNULA THAT APPEARED TO BE A MANUFACTURING ISSUE.

  Patient problems: Dyspnea

  MAUDE report 14408905 ↗
• MalfunctionDec 13, 2017Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THIS INNER CANNULA WAS IN USE ON A PATIENT AND THE CLINICIAN WAS UNABLE TO ADVANCE THE SUCTION CATHETER. THE PATIENT WAS NOT RECANNULATED AND THE TUBE REMAINED IN THE PATIENT. THE REPORTER STATED THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7114895 ↗