Shiley 50XLTCDRecalls & reported problems
Covidien LP · Tracheostomy Tube XLT Cuffed,Distal with Disposable Inner Cannula · Class 2
All models of Shiley (387)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884522028189), received between Mar 15, 2020 and Aug 18, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Gas/Air Leak” (2 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
- Gas/Air Leak2
Patient problems
- Extubate2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2020Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THIS COMPLAINT WAS WITH THE SAME PATIENT AND SAME PRODUCT SIZE THAT WAS REPORTED BEFORE. THE DEVICE WAS CHANGED DUE TO THE CUFF KEPT LEAKING, TINY LEAK. WHEN THE VENT WAS SET ON SECONDARY SETTINGS IT LEAKED MORE DUE TO THE HIGHER PRESSURE. THE LEAK KEPT GETTING WORSE. THE CUFF FAILED AND REQUIRED IMMEDIATE REPLACEMENT.
Patient problems: Extubate
MAUDE report 10421590 ↗InjuryMar 15, 2020Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE PATIENT NOTICED THAT THE CUFF OF THE DEVICE FEELS THAT IT WAS MUCH SOFTER AND HAD A LEAK. IT NEEDED TO BE REINFLATED A COUPLE OF TIMES. THE CUFF FAILED AND REQUIRED IMMEDIATE REPLACEMENT.
Patient problems: Extubate
MAUDE report 9833251 ↗
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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