Shiley 5.0PCF (UDI 20884521779720)Recalls & reported problems
Covidien LP · Pediatric Tracheostomy Tube with TaperGuard Cuff · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Shiley 5.0PCF pediatric tracheostomy tube is a cuffed breathing tube for children. Most of the 69 reports describe the cuff leaking air or not staying inflated, along with split or cracked tubing and difficulty removing the insertion stylet; several also mention the tube coming out when it was not intended. There are 5 reports of injuries and no 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
- 69
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 20884521779720), received between Dec 29, 2020 and Mar 2, 2026 — classified as 5 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (42 reports).
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 Problem42
- Gas/Air Leak28
- Material Split, Cut or Torn7
- Defective Component2
- Crack1
- Disconnection1
- Insufficient Device Problem Information1
- Mechanical Problem1
Patient problems
- Unintended Extubation43
- No Clinical Signs, Symptoms or Conditions37
- Insufficient Information12
- Hypoventilation3
- Hemorrhage/Blood Loss/Bleeding1
- Pressure Sore/Ulcer1
- Respiratory Failure1
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING USE, THE TWO TRACH TUBE'S STYLETS WERE DIFFICULT TO REMOVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24488922 ↗MalfunctionFeb 20, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TRACH TUBE'S CUFF DID NOT INFLATE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402682 ↗MalfunctionJan 20, 2026Use of Device Problem; Gas/Air Leak
IT WAS REPORTED THAT THE TRACH TUBE'S CUFF WILL NOT STAY INFLATED AS IT SHOULD, IT SLOWLY DEFLATES AS SOON AS THE SYRINGE WAS REMOVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 24120263 ↗MalfunctionOct 29, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE HAD A LEAK. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 23420901 ↗MalfunctionApr 30, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT A TRACHEOSTOMY TUBE EXPERIENCED CUFF AIR LEAKAGE. THE ISSUE OCCURRED IN A HOSPITAL SETTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 21934335 ↗MalfunctionDec 10, 2024Use of Device Problem; Defective Component; Use of Device Problem; Defective Component
ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE TRACHEOSTOMY TUBE HAD A HOLE AND THE PILOT BALLOON HAD A DAMAGE. IMMEDIATE REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 20888871 ↗MalfunctionOct 30, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT REMAIN INFLATED SHORTLY AFTER BEING IMPLANTED IN THE PATIENT. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 20570812 ↗MalfunctionOct 29, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE TWO TRACHEOSTOMY TUBE'S PILOT BALLOON DID NOT MAINTAIN PRESSURE. THE TRACH WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 20559226 ↗MalfunctionOct 25, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE TWO TRACHEOSTOMY TUBE'S PILOT BALLOON WERE DEFECTIVE. THE TRACH TUBES WERE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 20533760 ↗MalfunctionSep 27, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE AIR IN THE TRACHEOSTOMY TUBE'S CUFF STARTED LEAKING LITTLE BY LITTLE. EVEN WHEN AIR WAS PUT INTO THE CUFF, IT GRADUALLY LEAKS OUT. THE TRACH WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 20321839 ↗MalfunctionSep 20, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF THE TWO TRACHEOSTOMY TUBES HAD A LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 20274269 ↗MalfunctionSep 20, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF THE TWO TRACHEOSTOMY TUBES HAD A LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20274207 ↗MalfunctionAug 28, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, THE PROXIMAL SITE OF THE INFLATION LINE OF THE TRACHEOSTOMY TUBE "RUPTURED". THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 20085367 ↗MalfunctionAug 22, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA HAD A DEFECT IN THE CUFF, AS IT DID NOT REMAIN INFLATED SHORTLY AFTER BEING IMPLANTED IN THE PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 20038156 ↗MalfunctionAug 20, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA HAD A DEFECT IN THE CUFF, AS IT DID NOT REMAIN INFLATED SHORTLY AFTER BEING IMPLANTED IN THE PATIENT. THE TRACH WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 20008463 ↗MalfunctionAug 13, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE PROXIMATE SITE OF THE TRACHEOSTOMY TUBE'S INFLATION LINE WAS RUPTURED. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 19970755 ↗MalfunctionJul 10, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE TRACHEOSTOMY TUBE HAD A LEAK. THE REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 19713638 ↗MalfunctionJul 10, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE AIR GRADUALLY CAME OUT EVEN WHEN IT WAS ADDED TO THE CUFF OF THE TRACHEOSTOMY TUBE. THE REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 19713242 ↗MalfunctionJul 10, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE TRACHEOSTOMY TUBE HAD A LEAK. THE REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 19711904 ↗MalfunctionJun 27, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF DID NOT INFLATE BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629204 ↗MalfunctionJun 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, A TEAR IN THE CUFF WAS FOUND DURING PATIENT USE. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 19624908 ↗MalfunctionJun 17, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE PILOT BALLOON WAS OBSERVED TO BE DETACHED ON THE SECOND DAY AFTER THE TRACHEOSTOMY TUBE REPLACEMENT. THE TRACH WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 19553298 ↗MalfunctionMay 13, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INFLATION LINE WERE CUT DURING THE PROCEDURE. THE TRACH WAS REPLACED FOUR TIMES, BUT THE FOURTH TRACH'S CUT LINE WAS FOUND BEFORE USE.
Patient problems: Unintended Extubation
MAUDE report 19304664 ↗MalfunctionMay 13, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INFLATION LINE WERE CUT DURING THE PROCEDURE. THE TRACH WAS REPLACED FOUR TIMES, BUT THE FOURTH TRACH'S CUT LINE WAS FOUND BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19304590 ↗MalfunctionMay 13, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INFLATION LINE WERE CUT DURING THE PROCEDURE. THE TRACH WAS REPLACED FOUR TIMES, BUT THE FOURTH TRACH'S CUT LINE WAS FOUND BEFORE USE.
Patient problems: Unintended Extubation
MAUDE report 19304572 ↗
Other Tube tracheostomy and tube cuff devices
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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