Shiley 3.5NCF (UDI 20884521779553)Recalls & reported problems
Covidien LP · Neonatal Tracheostomy Tube with TaperGuard Cuff · Class 2
All models of Shiley (387)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521779553), received between Apr 24, 2024 and May 5, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak3
- Use of Device Problem2
Patient problems
- Unintended Extubation3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT EVEN WHEN AIR WAS INSERTED INTO THE TRACHEOSTOMY TUBE'S CUFF DURING THE PRE-CUFF CHECK, IT WOULD DEFLATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21961044 ↗MalfunctionOct 11, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S INFLATION LINE WAS FOUND BROKEN. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 20433572 ↗MalfunctionApr 24, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF THE TRACHEOSTOMY TUBE HAD AN AIR LEAK. THE PRESSURE WAS CHECK REGULARLY BUT THE PRESSURE DECREASED BY 5-10 CMH20 EACH TIME. THERE WERE ALSO 4 BATTERIES OF THE VIDEOLARYNGOSCOPE WHERE THE SCREEN DARKENED WHEN THE POWER WAS TURNED ON DURING A ROUTINE INSPECTION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175209 ↗MalfunctionApr 24, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE CUFFS OF THE TRACHEOSTOMY TUBE HAD AN AIR LEAK. THE PRESSURE WERE CHECK REGULARLY BUT THE PRESSURE DECREASED BY 5-10 CMH20 EACH TIME. REPLACEMENT OF THE TUBE DONE TWICE.
Patient problems: Unintended Extubation
MAUDE report 19175128 ↗MalfunctionApr 24, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE CUFFS OF THE TRACHEOSTOMY TUBE HAD AN AIR LEAK. THE PRESSURE WERE CHECK REGULARLY BUT THE PRESSURE DECREASED BY 5-10 CMH20 EACH TIME. REPLACEMENT OF THE TUBE DONE TWICE.
Patient problems: Unintended Extubation
MAUDE report 19174941 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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