Shiley 4.5NCF (UDI 20884521779577)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884521779577), received between Jun 20, 2022 and Jun 20, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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.
Most reported problems
Device problems
- Defective Device3
Patient problems
- Unintended Extubation3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2022Defective Device; Defective Device
ACCORDING TO THE REPORTER, DURING USE, THE INTRODUCER FEELS STIFF/RESISTANT ON ENTRY. THREE TUBES FROM THE SAME LOT NUMBER HAVE BEEN FOUND TO HAVE THE SAME PROBLEM. THE USER OF THIS PRODUCT HAS BEEN USING THIS FOR AROUND ONE YEAR NOW AND FAMILIAR WITH HOW THE INTRODUCER SHOULD FEEL.
Patient problems: Unintended Extubation
MAUDE report 14747777 ↗MalfunctionJun 20, 2022Defective Device; Defective Device
ACCORDING TO THE REPORTER, DURING USE, THE INTRODUCER FEELS STIFF/RESISTANT ON ENTRY. THREE TUBES FROM THE SAME LOT NUMBER HAVE BEEN FOUND TO HAVE THE SAME PROBLEM. THE USER OF THIS PRODUCT HAS BEEN USING THIS FOR AROUND 1 YEAR NOW AND FAMILIAR WITH HOW THE INTRODUCER SHOULD FEEL.
Patient problems: Unintended Extubation
MAUDE report 14744627 ↗MalfunctionJun 20, 2022Defective Device; Defective Device
ACCORDING TO THE REPORTER, DURING USE, THE INTRODUCER FELT STIFF/RESISTANT ON ENTRY. THREE TUBES FROM THE SAME LOT NUMBER HAVE BEEN FOUND TO HAVE THE SAME PROBLEM. THE USER OF THIS PRODUCT HAS BEEN USING THIS FOR AROUND 1 YEAR NOW AND FAMILIAR WITH HOW THE INTRODUCER SHOULD FEEL.
Patient problems: Unintended Extubation
MAUDE report 14744267 ↗
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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