Shiley 4.0NCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521103481), received between Jan 6, 2023 and Jan 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Use of Device 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A MANUAL INSPECTION OF CANNULA, BEFORE INSERTING TO THE PATIENT. AIR WAS INTRODUCED INTO THE CUFF THEN IMMERSED IN THE STERILE WATER. A LEAK FROM THE CUFF WAS REPORTED. ASKED FOR ANOTHER CANNULA BUT DURING INSPECTION IT WAS AGAIN FOUND OUT THAT THERE WAS A LEAK FROM THE CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113064 ↗
• MalfunctionJan 6, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A MANUAL INSPECTION OF CANNULA, BEFORE INSERTION. AN AIR WAS INTRODUCED INTO THE CUFF THEN IMMERSED IN THE STERILE WATER. A LEAK FROM THE CUFF WAS REPORTED. ASKED FOR ANOTHER CANNULA. DURING INSPECTION IT WAS AGAIN FOUND OUT THAT THERE WAS A LEAK FROM THE CUFF. THE THIRD DEVICE EXPLODED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112841 ↗