Shiley 5.0PEF (UDI 20884521101590)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20884521101590), received between Nov 2, 2020 and Jul 24, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K122531, K182861); they may or may not involve this specific model.

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.

• MalfunctionJul 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE FLANGE OF THE TRACHEOSTOMY TUBE BROKE APPROXIMATELY ONE WEEK OF USE. THE PATIENT HAD DIFFICULTY ACCEPTING THE TUBE AND REGULARLY PULLED THE TUBE TO DECANNULATE HIMSELF. REPLACEMENT OF THE TUBE WAS DONE USING A DIFFERENT MODEL AND EVERYTHING WAS BACK TO NORMAL.

  Patient problems: Unintended Extubation

  MAUDE report 22592610 ↗
• MalfunctionJul 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE FLANGE OF THE TRACHEOSTOMY TUBE BROKE AFTER ABOUT ONE WEEK OF USE. THE CHILD HAD DIFFICULTY ACCEPTING THE TUBE AND REGULARLY PULLS THE TUBE DECANNULATE HIMSELF. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 22592342 ↗
• MalfunctionJul 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED DURING TRACHEOSTOMY TUBE INSERTION, THE FLANGE BROKE. THE CHILD HAD DIFFICULTY ACCEPTING THE TUBE AND REGULARLY PULLS THE TUBE DECANNULATE HIMSELF. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 22584079 ↗
• MalfunctionNov 19, 2021Labelling, Instructions for Use or Training Problem; Defective Component; Labelling, Instructions for Use or Training Problem; Defective Component

  ACCORDING TO THE REPORTER, WHEN THE PATIENT'S TRACHEOSTOMY TUBE WAS CHANGED FROM 5.0PED TUBE TO 5.0PEF TUBE, IT WAS RUBBING AGAINST THE STOMA THAT CAUSED BLISTER TO THE PATIENT. THE SIZE OF THE ACTUAL PRODUCT WAS INCORRECT FROM THE LABEL OF THE PRODUCT'S PACKAGE.

  Patient problems: Blister

  MAUDE report 12846600 ↗
• InjuryNov 9, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A BROKEN CANNULA WING AND SLIPPED OUT OF THE TRACHEOSTOMA. THERE WAS NO PATIENT HARM.

  Patient problems: Low Oxygen Saturation; No Consequences Or Impact To Patient

  MAUDE report 10809231 ↗
• MalfunctionNov 2, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CANNULA WAS BROKEN ON THE WING AND SLIPPED OUT OF THE TRACHEOSTOMA. AFTER THE CANNULA SLIPPED OUT OF THE TRACHEOSTOMA, THE PULSE OXIMETER HAD AN ALARM OF SATURATION TOO LOW. THERE WAS NO PATIENT INJURY.

  Patient problems: Low Oxygen Saturation; No Consequences Or Impact To Patient

  MAUDE report 10774866 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122531, K182861. One submission often covers many models, so check the product and lot details in each record.

• Z-1951-2015 · May 8, 2015 · Terminated
  Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.