Shiley 3.5PEF (UDI 20884521101569)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521101569), received between Apr 10, 2024 and May 1, 2025 — classified as 2 injuries.

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

• InjuryMay 1, 2025Material Separation; Connection Problem; Material Separation; Connection Problem

  IT WAS REPORTED THAT THE PATIENT'S MOTHER FOUND THE TRACHEOTOMY TUBE DISLODGED AND WAS UNABLE TO LOCATE THE INNER CANNULA, BUT WAS ABLE TO REINSERT NEW TRACH WITHOUT ANY ISSUES. THE PATIENT STARTED TO PRESENT WITH BLOODY STOOLS THROUGHOUT THE DAY AND BECAME CONCERNED THAT THE PATIENT SWALLOWED THE INNER CANNULA AND WAS CAUSING DAMAGE TO THE GI TRACT. THE PATIENT HAD TO BE TAKEN TO THE OPERATING ROOM TO HAVE THE INNER CANNULA RETRIEVED FROM THE LEFT MAINSTEM.

  Patient problems: Aspiration/Inhalation; Device Embedded In Tissue or Plaque; Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 21943536 ↗
• InjuryApr 10, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE PATIENT PRESENTED STRIDOR AND RESPIRATORY DISTRESS FOR A WEEK, DUE TO THE TRACHEOSTOMY'S INNER CANULA SEPARATED FROM THE CANNULAR TUBE. BASED ON THE PHOTO PROVIDED. THE PATIENT WAS HOSPITALIZED AND THE TRACH WAS COMPLETELY EXPLANTED AND REPLACED. THE PATIENT WAS NOT DISCHARGED, DESPITE BEING STABLE.

  Patient problems: Foreign Body In Patient; Respiratory Insufficiency; Unintended Extubation

  MAUDE report 19083994 ↗

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.