Shiley 5.0PEF (UDI 20884521779799)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 20884521779799), received between May 10, 2021 and Jul 31, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (8 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.

• MalfunctionJul 31, 2026Material Separation

  Patient problems: Unintended Extubation

  MAUDE report 50107870 ↗
• MalfunctionJul 31, 2026Material Separation

  Patient problems: Unintended Extubation

  MAUDE report 50107866 ↗
• MalfunctionJan 20, 2026Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S FLANGES ALWAYS BREAK AT THE POINT WHERE THE NECK STRAP WAS ATTACHED. ONE EYELET WAS COMPLETELY BROKEN, ALWAYS ON THE SIDE WHERE TRACTION IS APPLIED. THE SECOND EYELET WAS CRACKED. THE TUBES WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24126223 ↗
• MalfunctionJan 20, 2026Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S FLANGES ALWAYS BREAK AT THE POINT WHERE THE NECK STRAP WAS ATTACHED. ONE EYELET WAS COMPLETELY BROKEN, ALWAYS ON THE SIDE WHERE TRACTION IS APPLIED. THE SECOND EYELET WAS CRACKED. THE TUBES WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24126216 ↗
• MalfunctionDec 29, 2025Crack; Crack

  IT WAS REPORTED THAT AFTER ONE MONTH OF PATIENT USAGE, THE TRACHEOSTOMY CANNULA CRACKED WITH A COMPLETE SEPARATION OF THE TWO PARTS OF THE CANNULA. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 23919095 ↗
• MalfunctionDec 17, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING USE OF THE TUBE, THE TRACHEOSTOMY CANNULA CRACKED AFTER THREE MONTHS OF PATIENT USAGE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 23835300 ↗
• MalfunctionAug 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, IT WAS FOUND THAT BOTH TRACH TUBE'S NECK FLANGE WERE DAMAGED, A CRACK FROM ONE PINHOLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797073 ↗
• MalfunctionAug 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, IT WAS FOUND THAT BOTH TRACH TUBE'S NECK FLANGE WERE DAMAGED, A CRACK FROM ONE PINHOLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797002 ↗
• MalfunctionApr 22, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT DURING USE, THERE WAS A BLUE LIKE DYE DISCOLORATION ON THE TRACH AFTER 15 DAYS OF PATIENT USE AS SHOWN IN THE IMAGE ATTACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882375 ↗
• MalfunctionMar 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE MOTHER WAS GIVING HER SON A BATH AND LIFTED UP HIS NECK TO CLEAN, A VERY LOUD LEAK OF AIR WAS HEARD COMING FROM THE TRACH. THE MOTHER EXAMINED THE TRACH AND NOTICED THAT THE SHAFT WAS SEVERED BELOW THE 15 MM CONNECTOR. THE MOTHER QUICKLY GOT ANOTHER TRACH AND REMOVED THAT ONE AND PUT IN A NEW TRACH WITHOUT ANY INCIDENT TO PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 21619837 ↗
• MalfunctionFeb 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING INSPECTION, THE FOUR TRACHEOSTOMY TUBE'S INTRODUCER (OBTURATOR) WERE PRESENTING JAMMING IN THE TUBE THAT HINDERED THE REMOVAL AFTER TUBE PLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353762 ↗
• MalfunctionFeb 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING INSPECTION, THE FOUR TRACHEOSTOMY TUBE'S INTRODUCER (OBTURATOR) WERE PRESENTING JAMMING IN THE TUBE THAT HINDERED THE REMOVAL AFTER TUBE PLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353697 ↗
• MalfunctionFeb 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING INSPECTION, THE FOUR TRACHEOSTOMY TUBE'S INTRODUCER (OBTURATOR) WERE PRESENTING JAMMING IN THE TUBE THAT HINDERED THE REMOVAL AFTER TUBE PLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353655 ↗
• MalfunctionFeb 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING INSPECTION, THE FOUR TRACHEOSTOMY TUBE'S INTRODUCER (OBTURATOR) WERE PRESENTING JAMMING IN THE TUBE THAT HINDERED THE REMOVAL AFTER TUBE PLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353547 ↗
• MalfunctionNov 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING INSPECTION, THE FOUR TRACHEOSTOMY TUBE'S INTRODUCER (OBTURATOR) WERE PRESENTING JAMMING IN THE TUBE THAT HINDERED THE REMOVAL AFTER TUBE PLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20603378 ↗
• MalfunctionNov 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING INSPECTION, THE FOUR TRACHEOSTOMY TUBE'S INTRODUCER (OBTURATOR) WERE PRESENTING JAMMING IN THE TUBE THAT HINDERED THE REMOVAL AFTER TUBE PLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20602414 ↗
• MalfunctionNov 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING INSPECTION, THE FOUR TRACHEOSTOMY TUBE'S INTRODUCER (OBTURATOR) WERE PRESENTING JAMMING IN THE TUBE THAT HINDERED THE REMOVAL AFTER TUBE PLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20602182 ↗
• MalfunctionNov 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING INSPECTION, THE FOUR TRACHEOSTOMY TUBE'S INTRODUCER (OBTURATOR) WERE PRESENTING JAMMING IN THE TUBE THAT HINDERED THE REMOVAL AFTER TUBE PLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600499 ↗
• InjuryDec 18, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, SOMETHING LIKE A SCRATCH APPEARED ON THE PATIENT'S JAWS BECAUSE OF THE INCREASED HEIGHT OF THE CONNECTOR PART OF THE TRACHEOSTOMY TUBE.

  Patient problems: Skin Inflammation/ Irritation; Unintended Extubation

  MAUDE report 18351459 ↗
• MalfunctionOct 14, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TUBE WAS BROKEN. THERE WAS NO REPORTED OUTCOME.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 15611905 ↗
• MalfunctionMay 10, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WERE CUTS WITH THE DEVICES' FLANGES. THE ONE SIDE OF BOTH DEVICES' FLANGES PINS WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798311 ↗
• MalfunctionMay 10, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WERE CUTS WITH THE DEVICES' FLANGES. THE ONE SIDE OF BOTH DEVICES' FLANGES PINS WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798249 ↗

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.