Shiley 4.0NEF (UDI 10884521097308)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521097308), received between Nov 17, 2020 and Sep 15, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Crack; Crack

  IT WAS REPORTED THAT A CRACK HAD DEVELOPED IN THE TRACHEOSTOMY CANNULA DURING USE. THE TUBE WAS REPLACED EARLIER THAN THE SCHEDULED DATE.

  Patient problems: Unintended Extubation

  MAUDE report 23054637 ↗
• InjuryNov 17, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE TUBE DISCONNECTED TO THE CONNECTOR. IT WAS INDICATED THAT THE PATIENT HAD MEDICAL HISTORY OF LARINGOMALASIA. IN ADDITION PATIENT HAD A CARDIORESPIRATORY ARREST. PATIENT HAD TO BE OPERATED ON IN ORDER TO REMOVE FOREIGN BODY (TRACHEOSTOMY TUBE). THE PATIENT IS REPORTED TO NOW BE IN STABLE CONDITION.

  Patient problems: Airway Obstruction; Apnea; Bradycardia; Cardiac Arrest; Discomfort; Foreign Body In Patient; Hypoxia; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Respiratory Failure; Unintended Extubation; Unintended Radiation Exposure

  MAUDE report 10850571 ↗

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.