Shiley 60XLTUDRecalls & reported problems
Covidien LP · Tracheostomy Tube XLT Cuffless,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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884522043687), received between Jun 28, 2022 and May 29, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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.
Reports received per month
Most reported problems
Device problems
- Material Separation2
- Use of Device Problem2
- Defective Component1
- Material Split, Cut or Torn1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Unintended Extubation3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE 6.0 MM TRACHEOSTOMY TUBE'S OBTURATOR DID NOT SMOOTHLY ENTER THE CANNULA AND SCRATCHED THE CANNULA PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105094 ↗MalfunctionMar 20, 2025Defective Component; Defective Component
IT WAS REPORTED THAT DURING USE, THE OBTURATOR OF THE TRACHEOSTOMY TUBE THAT FACILITATES THE PLACEMENT DID NOT FIT PROPERLY AND COMPLICATED THE PROCEDURE FOR THE HEALTHCARE PROVIDERS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21657506 ↗MalfunctionFeb 11, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT TRACHEOSTOMY TUBE BROKE DURING PATIENT USE AT THE TRACH'S NECK FLANGE, INDICATING A FAILURE ON THE TRACH TUBE FLANGE AS SHOWN IN THE IMAGE ATTACHED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 21358782 ↗MalfunctionFeb 6, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT TRACHEOSTOMY TUBE BROKE DURING PATIENT USE AT THE TRACH'S NECK FLANGE, INDICATING A FAILURE ON THE TRACH TUBE FLANGE AS SHOWN IN THE IMAGE ATTACHED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 21326295 ↗MalfunctionOct 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S TABS BROKE OFF AND THE TRACH FELL OUT OF THE PATIENT'S THROAT. THE PATIENT WENT TO THE EMERGENCY ROOM TO HAVE IT REPLACED.
Patient problems: Unintended Extubation
MAUDE report 20560540 ↗MalfunctionJun 28, 2022Material Separation; Material Separation
ACCORDING TO THE REPORTER, THE TRACH WAS BROKEN IN TWO. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14842008 ↗MalfunctionJun 28, 2022Material Separation; Material Separation
ACCORDING TO THE REPORTER, THE DEVICE WAS BROKEN IN TWO. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14841807 ↗
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 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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