Shiley 3.5PEF (UDI 20884521779768)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20884521779768), received between Jun 2, 2021 and Mar 20, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2025Disconnection; Material Separation; Disconnection; Material Separation

  IT WAS REPORTED THAT DURING USE, THE TRACHEOSTOMY TUBE BROKE OFF INTO THE PATIENT'S AIRWAY AFTER LESS THAN 2 WEEKS OF USAGE. THE EXTERNAL FLANGE WITH THE TIES AROUND THE NECK WAS NOT OVER THE STOMA. XRAY CONFIRMED THE INNER PART WAS IN HIS LOWER TRACHEA/BRONCHUS. THE PIECE OF THE TUBE WAS SURGICALLY REMOVED THE FROM THE PATIENT THAT REQUIRED GENERAL ANESTHESIA.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Unintended Extubation; Unintended Radiation Exposure

  MAUDE report 21654872 ↗
• InjuryFeb 25, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S OUTER CANNULA WAS BROKEN AT THE JUNCTION OF THE CANNULA AND THE NECK PLATE. THE ISSUE TOOK PLACE AT HOME, BUT THE PATIENT WAS ADMITTED TO THE HOSPITAL. BRONCHOSCOPY PROCEDURE WAS PERFORMED AND FRACTURED TRACHEOSTOMY WAS REMOVED AND REPLACED, THEN THE PATIENT WAS DISCHARGED NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21465579 ↗
• MalfunctionDec 6, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A CRACK IN THE PART OF THE FLANGE OF THE TRACHEOSTOMY TUBE WHERE THE NECK HOLDER PASSES THROUGH, 13 DAYS AFTER THE START OF USE. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 20863225 ↗
• MalfunctionNov 13, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER 23 DAYS OF USE, THE PART THROUGH WHICH THE FIXING STRING PASSES CRACKED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 20679702 ↗
• MalfunctionJul 11, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S FLANGE STARTED TO CRACK AFTER NINE DAYS OF PATIENT USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19720599 ↗
• MalfunctionJul 10, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PART OF THE FLANGE TO WHICH THE STRING WOULD PASS THROUGH BROKE. THE TRACHEOSTOMY WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19711696 ↗
• InjuryApr 10, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE PATIENT PRESENTED STRIDOR AND RESPIRATORY DISTRESS, WHICH BECAME ACCENTUATED TOWARDS THE ENTIRE WEEK DUE TO THE TRACHEOSTOMY'S INNER CANULA SEPARATED FROM THE CANNULAR TUBE BASED ON THE PHOTO PROVIDED. THE TRACH WAS REPLACED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Respiratory Insufficiency; Unintended Extubation

  MAUDE report 19081464 ↗
• MalfunctionNov 29, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S FLANGE HAD A CRACK BASED ON THE PHOTO PROVIDED, DURING USED. THE TUBE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 18225642 ↗
• MalfunctionMar 30, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY INSERTING THE OBTURATOR, IT WAS VERY STIFF WHEN TRIED TO PASS BEYOND THE CURVE OF THE TUBE WHILE PREPARING THE TUBE IN THE EVENT OF AN EMERGENCY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16648442 ↗
• MalfunctionJun 2, 2021Disconnection; Disconnection

  ACCORDING TO THE REPORTER, A PATIENT WITH INFECTION HAD A LOT OF SECRETIONS AND THE ¿GÄNSEGURGEL" COULD NOT BE REMOVED FROM THE PRODUCT DURING A PROCEDURE. THE PROBLEM WAS NOT SOLVED WITH PEAN. THE PATIENT HAD A CANNULA CHANGE AND BECAME STABLE. THE PRODUCT HAD NO DEFECT, BUT THE CUSTOMER WAS COMPLAINING ABOUT THE CONNECTIVITY OF THE PRODUCT TO OTHER DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 11923300 ↗

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.