Shiley 5.0PELF (UDI 20884521101613)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20884521101613), received between Nov 16, 2021 and Oct 17, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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.

• MalfunctionOct 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE WAS FOUND TORN OR CAME LOOSE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20471336 ↗
• MalfunctionOct 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE WAS FOUND TORN OR CAME LOOSE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20471240 ↗
• MalfunctionSep 23, 2024Contamination /Decontamination Problem; Human-Device Interface Problem; Contamination /Decontamination Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USE, SINCE CHANGING FROM THE OLD TRACH TO THE NEW, SOMETHING LIKE BLACK MOLD STARTED TO GROW ON THE INSIDE OF THE TUBE. THERE WAS NO REPORTED PATIENT HARM.

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

  MAUDE report 20287756 ↗
• MalfunctionApr 4, 2022Use of Device Problem; Physical Resistance/Sticking; Use of Device Problem; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE NEW DESIGN WOULD NOT LET THE MOTHER INSERT THE INDUCER INTO THE TRACHEOSTOMY, WITHOUT USING A LOT OF FORCE, WHICH WAS NOT CORRECT. THE SAME AMOUNT OF FORCE WAS THEN NEEDED TO REMOVE THE INDUCER FROM THE TRACHEOSTOMY, ONCE THE TRACHY WAS INSITU, WHICH PLACES PATIENT'S AT RISK OF TUBE REMOVAL. THE MOTHER WAS FORCED TO INSERT THE TRACH WITHOUT THE INDUCER, WHICH WAS DIFFICULT AND PLACES THE PATIENT AT RISK OF TRAUMA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14000962 ↗
• MalfunctionMar 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE PATIENT WAS DECANNULATED MANY TIMES WHEN STARTED USING THE NEW TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 13966270 ↗
• MalfunctionNov 16, 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 12822903 ↗

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.