Shiley 4.0PEF (UDI 20884521101576)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20884521101576), received between Dec 28, 2020 and Sep 4, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE PATIENT'S MOTHER ATTEMPTED TO INSERT THE TRACHEOSTOMY TUBES, ALL THREE WERE FOUND TO BE BROKEN. AN OLDER TRACH TUBE HAD TO BE USED INSTEAD AND RESULTED THE RISK OF INFECTION.

  Patient problems: Unintended Extubation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22962802 ↗
• InjurySep 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE PATIENT'S MOTHER ATTEMPTED TO INSERT THE TRACHEOSTOMY TUBES, ALL THREE WERE FOUND TO BE BROKEN. AN OLDER TRACH TUBE HAD TO BE USED INSTEAD AND RESULTED THE RISK OF INFECTION.

  Patient problems: Unintended Extubation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22962775 ↗
• InjurySep 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE PATIENT'S MOTHER ATTEMPTED TO INSERT THE TRACHEOSTOMY TUBES, ALL THREE WERE FOUND TO BE BROKEN. AN OLDER TRACH TUBE HAD TO BE USED INSTEAD AND RESULTED THE RISK OF INFECTION.

  Patient problems: Unintended Extubation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22962753 ↗
• MalfunctionOct 7, 2024Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE THREE TRACHEOSTOMY TUBES WERE FOUND BROKEN IN THE SAME SPOT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384234 ↗
• MalfunctionOct 7, 2024Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE THREE TRACHEOSTOMY TUBES WERE FOUND BROKEN IN THE SAME SPOT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384231 ↗
• MalfunctionMar 15, 2024Disconnection; Disconnection

  ACCORDING TO THE REPORTER, ONE OF THE TRACHEOSTOMY TUBE'S FLANGE WAS BROKEN AFTER TWO WEEKS SINCE THE START OF USE. IT WAS STATED THAT THE EVENT OCCURRED DURING USE WITH THE A NECK HOLDER. THE FLANGE WAS NOT COMPLETELY SEPARATED FROM THE HUB BUT THE ENTIRE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18917525 ↗
• InjuryDec 28, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE PATIENT IS A CHRONIC TRACH PATIENT SINCE THE AGE OF (B)(6) MONTHS AND HAD BEEN USING A 4.0PED TRACH AT HOME WITHOUT INCIDENT. WHEN HOSPITALIZED IN AUGUST FOR A NON-RELATED INFECTION, THE PATIENT HAD AN UNDERLYING FEVER AND WAS ON ANTIBIOTICS IN THE HOSPITAL AT WHICH TIME THE TRACH WAS REPLACED WITH A 4.0PEF. AFTER TWO DAYS OF USING THE DEVICE, THE PATIENT HAD MARKED REDNESS WITHOUT BREAKDOWN ON THE NECK AROUND THE AREA THAT CAME IN CONTACT WITH THE TRACH FLANGE. THE TRACH WAS REPLACED WITH A 4.0PED AND THE REDNESS CLEARED UP QUICKLY. NORMAL PRACTICE FOR THIS PATIENT HAD BEEN TO USE A 2X2 GAUZE PAD UNDER THE FLANGE. THIS PRACTICE DID NOT CHANGE WHEN THE NEW TRACH WAS PLACED.

  Patient problems: Skin Inflammation/ Irritation; Unintended Extubation

  MAUDE report 11074763 ↗

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.