Shiley 3.0PEF (UDI 20884521779751)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521779751), received between Nov 17, 2021 and Aug 15, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (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.

• MalfunctionAug 15, 2022Disconnection; Disconnection

  ACCORDING TO THE REPORTER, DURING USE, THE TUBE BROKE A FEW DAYS AFTER PLACEMENT. RECANNULATION WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 15227723 ↗
• InjuryNov 17, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT WAS INITIALLY CANNULATED WITH 3.0 AND CHANGED TO 3.0 IN THE CLINIC. THE MOTHER OF THE CHILD REPORTED IRRITABILITY AND INCREASED SECRETIONS DURING TIE CHANGES THAT WERE DIFFERENT FROM NORMAL. AN AMBULANCE WAS CALLED OUT FOR INCREASED WORK OF BREATHING (WOB) AND POSSIBLE PARTIAL OCCLUSION OF THE TUBE, ONCE CHANGED SYMPTOMS RESOLVED. THE MOTHER REPORTED SINCE THE CHANGE, THE CHILD HAD INCREASED IRRITABILITY AND SECRETIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12828847 ↗

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.