Shiley 5.5PEF (UDI 20884521779805)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 20884521779805), received between Dec 14, 2022 and Jan 23, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY FLANGE'S LEFT WING WAS BROKEN DURING USE. THE CANNULA WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24165630 ↗
• MalfunctionDec 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S FLANGE WAS BROKEN FROM THE PINHOLES, AS SHOWN IN THE ATTACHED IMAGE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 23704985 ↗
• MalfunctionDec 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S FLANGE WAS BROKEN FROM THE PINHOLES, AS SHOWN IN THE ATTACHED IMAGE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 23704964 ↗
• MalfunctionMay 15, 2025Use of Device Problem; Patient-Device Incompatibility; Use of Device Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE FLANGE WAS DAMAGED, AND SELF EXTRACTED. THIS WAS THE FOURTH TIME THIS EVENT OCCURRED WITH THE SAME DEVICE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22028174 ↗
• MalfunctionMar 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING ROUTINE TRACH TUBE CHANGE AT HOME, IT WAS NOTED THAT THERE WAS A CRACK OR TEAR ON THE LEFT SIDE OF THE FLANGE WHERE IT WAS CONNECTED TO THE TRACH CONNECTOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21569678 ↗
• MalfunctionDec 2, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE FLANGE OF THE TRACHEOSTOMY TUBE BROKE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 20828242 ↗
• MalfunctionNov 7, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE NECK FLANGE OF THE TRACHEOSTOMY TUBE CRACKED AFTER INTUBATION AND WAS IN DANGER OF FALLING OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 20631330 ↗
• MalfunctionAug 21, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD A BROKEN FLANGE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 20009767 ↗
• MalfunctionAug 15, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE FOUR TRACHEOSTOMY TUBES HAD BROKEN FLANGES. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 19993286 ↗
• MalfunctionAug 15, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE FOUR TRACHEOSTOMY TUBES HAD BROKEN FLANGES. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 19993040 ↗
• MalfunctionAug 15, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE FOUR TRACHEOSTOMY TUBES HAD BROKEN FLANGES. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 19992948 ↗
• MalfunctionAug 15, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE FOUR TRACHEOSTOMY TUBES HAD BROKEN FLANGES. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 19992688 ↗
• MalfunctionMay 7, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER 3 WEEKS OF PATIENT USAGE, THE FLANGE OF THE TRACHEOSTOMY TUBE WAS "RUPTURED". THE PATIENT'S MOTHER ONLY MADE A FIXATION USING A STRING. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19263649 ↗
• MalfunctionApr 23, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S NECK HOLDER BROKE WHEN TRIED TO REPLACE DURING USE. WHEN THE NECK FLANGE WAS SUPPORTED BY HAND, IT WAS DAMAGED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169802 ↗
• MalfunctionApr 15, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S NECK HOLDER BROKE WHEN TRIED TO REPLACE DURING USE. WHEN THE NECK FLANGE WAS SUPPORTED BY HAND, IT WAS DAMAGED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106109 ↗
• MalfunctionSep 13, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE FILTER WAS UNABLE TO CONNECT FIRMLY IN THE CONNECTOR PART OF THE TRACH. THE HEIGHT EXCEEDS, TOUCHING THE PATIENT'S JAW. THERE WAS TIGHTNESS WHEN CONNECTING, AND THE SLIP WAS ALSO POOR. THE DEVICE WAS REPLACED DURING THE NEXT REPLACEMENT PERIOD. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740932 ↗
• MalfunctionMay 1, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE OBTURATOR WAS TOO TIGHT THAT A LUBRICANT WAS REQUIRED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16844635 ↗
• MalfunctionMay 1, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE OBTURATOR WAS TOO TIGHT THAT A LUBRICANT WAS REQUIRED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16844575 ↗
• MalfunctionMay 1, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE OBTURATOR WAS TOO TIGHT THAT A LUBRICANT WAS REQUIRED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16843660 ↗
• MalfunctionApr 28, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE OBTURATOR WAS TOO TIGHT THAT A LUBRICANT WAS REQUIRED DURING THE PROCEDURE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 16832020 ↗
• MalfunctionApr 27, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE OBTURATOR WAS TOO TIGHT THAT A LUBRICANT WAS REQUIRED DURING THE PROCEDURE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 16828627 ↗
• MalfunctionDec 14, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, ONE OF THE FLANGE PIN WAS BROKEN. THE TRACHEOSTOMY TUBE HAD TO BE CHANGED. THE CUSTOMER ALSO REPORTED THAT THE TRACH TUBE HAD A YELLOW COLOR AFTER TWO WEEKS OF USE.

  Patient problems: Unintended Extubation

  MAUDE report 15982009 ↗

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.