Shiley 50XLTCPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884522027929), received between Dec 30, 2024 and Jan 10, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Installation-Related Problem; Installation-Related Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SCOPE WENT THROUGH THE TUBE EASILY UNTIL IT REACHED THE END, AND THERE WAS A LIP FOUND. A SECOND TRACHEOSTOMY TUBE WAS CHECKED AND HAD THE SAME LIP AT THE END. NEED TO CHANGE OUT THE SIZE TO FIT THE SCOPE EVEN THOUGH LOOKING AT THE NUMBERS IT SHOULD HAVE FIT THE SIZE 5. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 21121422 ↗
• MalfunctionJan 10, 2025Installation-Related Problem; Installation-Related Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SCOPE WENT THROUGH THE TUBE EASILY UNTIL IT REACHED THE END, AND THERE WAS A LIP FOUND. A SECOND TRACHEOSTOMY TUBE WAS CHECKED AND HAD THE SAME LIP AT THE END. NEED TO CHANGE OUT THE SIZE TO FIT THE SCOPE EVEN THOUGH LOOKING AT THE NUMBERS IT SHOULD HAVE FIT THE SIZE FIVE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21121419 ↗
• MalfunctionDec 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THREE TRACHEOSTOMY TUBES HAD SMALL PLASTIC PIECES BREAKING, THESE ARE THE PIECES THAT CONNECT THE INNER CANNULA, WHERE IT HAS TO BE PUSHED IN AND TWISTED SLIGHTLY TO HOLD INTO PLACE. TUBES WERE REPLACED ACCORDINGLY.

  Patient problems: Unintended Extubation

  MAUDE report 21044399 ↗
• MalfunctionDec 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THREE TRACHEOSTOMY TUBES HAD SMALL PLASTIC PIECES BREAKING, THESE ARE THE PIECES THAT CONNECT THE INNER CANNULA, WHERE IT HAS TO BE PUSHED IN AND TWISTED SLIGHTLY TO HOLD INTO PLACE. TUBES WERE REPLACED ACCORDINGLY.

  Patient problems: Unintended Extubation

  MAUDE report 21044396 ↗
• MalfunctionDec 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THREE TRACHEOSTOMY TUBES HAD SMALL PLASTIC PIECES BREAKING, THESE ARE THE PIECES THAT CONNECT THE INNER CANNULA, WHERE IT HAS TO BE PUSHED IN AND TWISTED SLIGHTLY TO HOLD INTO PLACE. TUBES WERE REPLACED ACCORDINGLY.

  Patient problems: Unintended Extubation

  MAUDE report 21044262 ↗