Shiley 50XLTINRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 60884522006717), received between Nov 4, 2019 and May 9, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULA'S BLUE CONNECTOR DETACHED FROM THE CANNULA. THE INNER CANNULA WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993137 ↗
• MalfunctionMay 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULA'S BLUE CONNECTOR DETACHED FROM THE CANNULA. THE INNER CANNULA WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961825 ↗
• MalfunctionFeb 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE 5.0MM TRACH INNER CANNULA WAS DIFFICULT TO LOCK INTO THE TRACH. THEY DO FIT BUT WITH CONSIDERABLE FIDDLING TO LINE THEM UP AND LOCK IN PLACE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410286 ↗
• MalfunctionNov 21, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING USE, THE BLUE ATTACHMENT PIECE OF THE DEVICE FELL OFF AND IT COULD NOT BE CONNECTED TO THE TRACH TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835677 ↗
• MalfunctionJun 15, 2021Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, ONE OF INNER CANNULAS CRIMPED CLOSED AFTER ONE PASS OF THE SUCTION CATHETER. ONCE IT WAS REMOVED, THE NURSE NOTICED THAT THE MATERIAL WAS MUCH THINNER THAN THE OTHER INNER CANNULAS INCLUDED IN THE BOX. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12002675 ↗
• MalfunctionNov 4, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT INNER CANNULA WAS BREAKING AT THE BLUE TWIST LOCK. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9274799 ↗