Shiley 4.5PEF (UDI 20884521101583)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20884521101583), received between Aug 28, 2020 and Oct 8, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface 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. 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 8, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER 3 DAYS OF PATIENT USE, THE TRACHEOSTOMY TUBE'S NECK FLANGE FIXING HOLE WAS FOUND BROKEN AS SHOWN IN THE ATTACHED IMAGE. THE TUBE WAS REPLACED.

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

  MAUDE report 20395564 ↗
• MalfunctionJan 16, 2024Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT MISTAKENLY KICKED AND APPLIED TENSION TO THE TRACHEOSTOMY TUBE WITH THEIR OWN FOOT, AND SELF- EXTUBATION MISTAKENLY OCCURRED TWO TO THREE DAYS AFTER INTUBATION. WHEN THAT TUBE WAS CHECKED, IT WAS CONFIRMED THAT THERE WAS A CRACK IN ONE OF THE PINHOLES OF THE NECK FLANGE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18518518 ↗
• InjuryApr 20, 2022Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE CLEAR FLANGE OF THE DEVICE WAS COLLECTED OF A MILKY FILM COATING AND THEN WOULD FLAKE OFF. THE DEVICE HAD A LOT MORE MUCOUS PLUGGING THAN NORMAL. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Bacterial Infection; Unintended Extubation

  MAUDE report 14160418 ↗
• InjuryApr 20, 2022Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE CLEAR FLANGE OF THE DEVICE WAS COLLECTED OF A MILKY FILM COATING AND THEN WOULD FLAKE OFF. THE DEVICE HAD A LOT MORE MUCOUS PLUGGING THAN NORMAL. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Bacterial Infection; Unintended Extubation

  MAUDE report 14160342 ↗
• InjuryApr 20, 2022Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE CLEAR FLANGE OF THE DEVICE WAS COLLECTED OF A MILKY FILM COATING AND THEN WOULD FLAKE OFF. THE DEVICE HAD A LOT MORE MUCOUS PLUGGING THAN NORMAL. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Bacterial Infection; Unintended Extubation

  MAUDE report 14160275 ↗
• InjuryAug 28, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT HAD AN ALLERGIC REACTION AROUND THE STOMA FROM THE DEVICE. THE PATIENT WAS RECANNULATED.

  Patient problems: Extubate; Skin Inflammation/ Irritation; Unintended Extubation

  MAUDE report 10465489 ↗

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.