Shiley 3.5NEFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521779607), received between May 18, 2021 and Jul 12, 2022 — classified as 2 malfunctions.

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

• MalfunctionJul 12, 2022Defective Device; Defective Device

  ACCORDING TO THE REPORTER, THE PRODUCT WAS CHECK VISUALLY PRIOR TO USE, IT WAS FOUND THAT THE INTRODUCER WAS DIFFICULT TO PASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14992427 ↗
• MalfunctionMay 18, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT HAD A RASH FOR A COUPLE OF MONTHS. TRIED OINTMENTS BUT IT WOULD NOT HELP. THE RASH WAS SPECIFICALLY AT THE TRACH AREA AND WAS CONFIRMED AS CONTACT DERMATITIS (RASH IS AN ANGRY RED LIKE A HEAT RASH. NO BLISTERS). IT WAS STATED THAT THE PATIENT SWITCHED FROM WHITE HUB TO CLEAR HUB AND HAD AN ALLERGY SINCE. THE PATIENT IS OK BUT CONTINUES TO GET RASHES LOCALIZED TO THE TRACH SITE THAT CAUSED DISCOMFORT.

  Patient problems: Contact Dermatitis

  MAUDE report 11840953 ↗

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.