Shiley 5.0PELF (UDI 20884521779874)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884521779874), received between Oct 31, 2021 and Feb 6, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE, THE TRACHEOSTOMY TUBE HAD AN AIR LEAK. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21326407 ↗
• MalfunctionNov 21, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S OBTURATOR (STYLET) WAS THICKER THAN THE FORMER, AND THE INNER WALL OF THE TUBE WAS DEFORMED WHEN BEING INSERTED OR REMOVED. THE OBTURATOR WITH RESISTANCE ENOUGH TO CAUSE THE TUBE TO RISE COULD NOT BE USED. A NEW UNIT WAS OPENED, AND THE SAME THING OCCURRED, SO THE TUBE WAS CONTINUOUSLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188212 ↗
• MalfunctionNov 13, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S OBTURATOR (STYLET) WAS THICKER THAN THE FORMER, AND THE INNER WALL OF THE TUBE WAS DEFORMED WHEN BEING INSERTED OR REMOVED. THE OBTURATOR WITH RESISTANCE ENOUGH TO CAUSE THE TUBE TO RISE COULD NOT BE USED. A NEW UNIT WAS OPENED, AND THE SAME THING OCCURRED, SO THE TUBE WAS CONTINUOUSLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18119099 ↗
• InjuryAug 15, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WAS BROKE. THE PATIENT ALMOST WENT TO THE EMERGENCY ROOM. THERE WAS NO PATIENT HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 15227487 ↗
• MalfunctionMay 21, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACH FLANGE WAS BROKEN. THEY MADE AN EMERGENCY TRACH CHANGE.

  Patient problems: Unintended Extubation

  MAUDE report 14465181 ↗
• MalfunctionDec 6, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD SHORT DURATION OF CANNULA. CHANGE OF CANNULA WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 12932995 ↗
• MalfunctionOct 31, 2021Disconnection; Use of Device Problem; Disconnection; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER TWO DAYS OF USE, THE DEVICE'S FLANGE WAS DAMAGED AND FELL OUT OF THE PATIENT. REPLACEMENT OF THE TRACH WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 12725586 ↗
• MalfunctionOct 31, 2021Disconnection; Use of Device Problem; Disconnection; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER TWO DAYS OF USE, THE DEVICE'S FLANGE WAS DAMAGED AND FELL OUT OF THE PATIENT. REPLACEMENT OF THE TRACH WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 12725584 ↗
• MalfunctionOct 31, 2021Disconnection; Use of Device Problem; Disconnection; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER TWO DAYS OF USE, THE DEVICE'S FLANGE WAS DAMAGED AND FELL OUT OF THE PATIENT. REPLACEMENT OF THE TRACH WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 12725582 ↗

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.