Shiley 4.0NEF (UDI 20884521779614)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521779614), received between Mar 8, 2021 and Mar 8, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Component” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD DIMENSIONAL ISSUE. THE PATIENT DID NOT REACH THE OPTIMAL SATURATION FOR HER CONDITION, AND HAD TO REPLACED THE DEVICE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 11434935 ↗

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.