Shiley 4.5PEF (UDI 20884521779782)Recalls & reported problems
Covidien LP · Pediatric Tracheostomy Tube Cuffless · Class 2
Quick summary
This Shiley 4.5PEF cuffless pediatric tracheostomy tube keeps a child's airway open without an inflatable cuff. The 27 reports mostly describe the tube coming out of place on its own, along with a broken wing or flange that let the cannula release, plus some discoloration of the material. Five reports involved injuries and none involved deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 20884521779782), received between Jun 29, 2021 and Aug 24, 2026 — classified as 5 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (13 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem13
- Material Discolored6
- Appropriate Device Problem Term/Code Not Available4
- Human-Device Interface Problem2
- Defective Component1
- Disconnection1
- Obstruction of Flow1
Patient problems
- Unintended Extubation19
- No Clinical Signs, Symptoms or Conditions9
- Respiratory Tract Infection4
- Insufficient Information3
- Loss of consciousness1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50419863 ↗MalfunctionAug 13, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50244396 ↗MalfunctionApr 16, 2026Use of Device Problem
IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S RIGHT PART FLANGE WAS FOUND BROKEN. IT WAS SEPARATED ENOUGH FOR THE CANNULA FIXATION TO RELEASE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24904422 ↗MalfunctionApr 16, 2026Use of Device Problem
IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S RIGHT PART FLANGE WAS FOUND BROKEN. IT WAS SEPARATED ENOUGH FOR THE CANNULA FIXATION TO RELEASE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24904233 ↗MalfunctionApr 16, 2026Use of Device Problem
IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S RIGHT PART FLANGE WAS FOUND BROKEN. IT WAS SEPARATED ENOUGH FOR THE CANNULA FIXATION TO RELEASE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24898766 ↗MalfunctionApr 16, 2026Use of Device Problem
IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S RIGHT PART FLANGE WAS FOUND BROKEN. IT WAS SEPARATED ENOUGH FOR THE CANNULA FIXATION TO RELEASE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24898371 ↗MalfunctionJan 23, 2026Use of Device Problem
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S FLAP BROKE WHILE BEING USED ON A PATIENT WITH COGNITIVE IMPAIRMENT. THE CANNULA WAS CHANGED.
Patient problems: Unintended Extubation
MAUDE report 24165525 ↗InjuryOct 30, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A HEALTHCARE PERSONNEL DISCOVERED A PATIENT WHO WAS HYPORESPONSIVE AND UNCONSCIOUS IN THEIR UNIT. UPON EVALUATION, THE PATIENT WAS FOUND TO BE DECANNULATED DUE TO THE BROKEN RIGHT WING OF THE CANNULA. THE CANNULA WAS REPLACED.
Patient problems: Loss of consciousness; Unintended Extubation
MAUDE report 23429988 ↗MalfunctionOct 22, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD A BROKEN FLANGE RIGHT WING AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23360788 ↗MalfunctionOct 22, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD A BROKEN RIGHT WING FLANGE AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23360779 ↗MalfunctionAug 26, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE ONE PART OF THE NECK FLANGE BROKE DURING USE. THE TUBE WAS REPLACED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 22892871 ↗MalfunctionOct 9, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S NECK FLANGE WAS FOUND CRACKED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20408086 ↗MalfunctionNov 29, 2023Disconnection; Disconnection
ACCORDING TO THE REPORTER, THE NECK FLANGE OF THE TRACHEOSTOMY TUBE WAS DISLODGED AND DAMAGED AFTER LESS THAN A MONTH OF BEING USED. REPLACEMENT WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 18234805 ↗MalfunctionOct 30, 2023Material Discolored; Material Discolored
ACCORDING TO THE REPORTER, THERE WAS A BLACK DISCOLORATION INSIDE THE LUMEN OF THE TRACHEOSTOMY TUBE. THE TUBE WAS REPLACED BY ANOTHER MANUFACTURER. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 18035908 ↗MalfunctionOct 27, 2023Material Discolored; Material Discolored
ACCORDING TO THE REPORTER, THERE WAS A BLACK DISCOLORATION INSIDE THE LUMEN OF THE TRACHEOSTOMY TUBE. THE TUBE WAS REPLACED BY ANOTHER MANUFACTURER.
Patient problems: Unintended Extubation
MAUDE report 18025421 ↗MalfunctionOct 27, 2023Material Discolored; Material Discolored
ACCORDING TO THE REPORTER, THERE WAS A BLACK DISCOLORATION INSIDE THE LUMEN OF THE TRACHEOSTOMY TUBE. THE TUBE WAS REPLACED BY ANOTHER MANUFACTURER.
Patient problems: Unintended Extubation
MAUDE report 18025350 ↗MalfunctionOct 24, 2023Material Discolored; Material Discolored
ACCORDING TO THE REPORTER, THERE WAS A BLACK DISCOLORATION INSIDE THE LUMEN OF THE TRACHEOSTOMY TUBE. THE TUBE WAS REPLACED BY ANOTHER MANUFACTURER.
Patient problems: Unintended Extubation
MAUDE report 17998439 ↗MalfunctionOct 20, 2023Material Discolored; Material Discolored
ACCORDING TO THE REPORTER, BOTH TRACHEOSTOMY TUBE FROM THE TIME IT WAS EXTUBATED FROM THE PATIENT, THE LUMEN HAD FOUND A BLACK DISCOLORATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17981133 ↗MalfunctionOct 20, 2023Material Discolored; Material Discolored
ACCORDING TO THE REPORTER, BOTH TRACHEOSTOMY TUBE FROM THE TIME IT WAS EXTUBATED FROM THE PATIENT, THE LUMEN HAD FOUND A BLACK DISCOLORATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17981121 ↗InjuryJul 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, DURING USE, THE PATIENT COULD NOT TOLERATE THE DEVICE. THE SECRETIONS WOULD CHANGE AND PLUGGING WOULD START OCCURRING TO INCLUDE A BS SOUNDING WHEEZY. THE PATIENT HAD A REPLACEMENT OF THE DEVICE.
Patient problems: Respiratory Tract Infection; Unintended Extubation
MAUDE report 14945481 ↗InjuryJul 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, DURING USE, THE PATIENT COULD NOT TOLERATE THE DEVICE. THE SECRETIONS WOULD CHANGE AND PLUGGING WOULD START OCCURRING TO INCLUDE A BS SOUNDING WHEEZY. THE PATIENT HAD A REPLACEMENT OF THE DEVICE.
Patient problems: Respiratory Tract Infection; Unintended Extubation
MAUDE report 14945174 ↗InjuryJul 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, DURING USE, THE PATIENT COULD NOT TOLERATE THE DEVICE. THE SECRETIONS WOULD CHANGE AND PLUGGING WOULD START OCCURRING TO INCLUDE A BS SOUNDING WHEEZY. THE PATIENT HAD A REPLACEMENT OF THE DEVICE.
Patient problems: Respiratory Tract Infection; Unintended Extubation
MAUDE report 14945102 ↗MalfunctionMay 26, 2022Human-Device Interface Problem; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING USE, THE PATIENT COULD NOT TOLERATE THE DEVICE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 14518021 ↗InjuryMay 26, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, FOR 6 DAYS, MULTIPLE PLUGS WERE REMOVED WITH STERILE Q-TIPS THAT SALINE AND SUCTION COULD NOT REMOVE. THE PATIENT DEVELOPED PSEUDOMONAS.
Patient problems: Respiratory Tract Infection
MAUDE report 14507749 ↗MalfunctionMay 25, 2022Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A LOT MORE MUCOUS PLUGGING THAN NORMAL. THE RELATIVE OF THE PATIENT HAS TO CLEAN THE SHAFT OUT AT LEAST TWO OR THREE TIMES A DAY THAT WAS UNCOMMON TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 14497582 ↗
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 · TerminatedShiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
Other Tube tracheostomy and tube cuff devices
- Shiley 8CN85HCovidien LP · Tube tracheostomy and tube cuff1 recall2 deaths354 reports
- Shiley 6CN75HCovidien LP · Tube tracheostomy and tube cuff1 recall3 deaths240 reports
- Shiley 7CN80RCovidien LP · Tube tracheostomy and tube cuff2 recalls148 reports
- Bivona 67PFSS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall166 reports
- Bivona 670180Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall140 reports
- Bivona 670170Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall10 deaths132 reports
- Shiley 6CN75RCovidien LP · Tube tracheostomy and tube cuff1 recall1 death121 reports
- Bivona 67PFSS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall115 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.