Shiley 6CN75EDRecalls & reported problems
Covidien LP · Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff Disposable Inner Cannula · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521726215), received between Jan 6, 2023 and Jun 16, 2026 — classified as 1 injury, 4 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
- Connection Problem2
Patient problems
- Unintended Extubation4
- Insufficient Information1
- Low Oxygen Saturation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THE CUFFS OF TWO TRACHEOSTOMY TUBES KEPT DEFLATING, WHICH REQUIRED THE TUBES TO BE REPLACED INTERCHANGEABLY. THIS RESULTED IN HAVING TO CHANGE TO A DIFFERENT SIZED TRACH.
Patient problems: Unintended Extubation
MAUDE report 25527267 ↗MalfunctionMar 17, 2026Gas/Air Leak
IT WAS REPORTED THAT AS THE VENTILATOR ALARM SOUND, A TRACHEOSTOMY TUBE'S CUFF LEAK WAS SUSPECTED DURING USE. THEREFORE, THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24622227 ↗MalfunctionMar 17, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS DAMAGED AND HAD A LEAK. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 21618690 ↗MalfunctionApr 24, 2023Connection Problem; Connection Problem
ACCORDING TO THE REPORTER, THE 15MM CONNECTOR OF THE DEVICE WAS NOT FIT SECURELY WITH OTHER COMPANY'S HME DEVICE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.
Patient problems: Unintended Extubation
MAUDE report 16801790 ↗InjuryJan 6, 2023Connection Problem; Connection Problem
ACCORDING TO THE REPORTER, THE PATIENT TOLERATED CAP AND TRACH WITHOUT INNER CANNULA IN PLACED FOR TWENTY FOUR HOURS. WHEN INNER CANNULA WAS PLACED AND RECAPPED, THE PATIENT'S OXYGEN SATURATION DECREASED. CONFIRMED CORRECT INNER CANNULA WAS IN PLACED. REMOVED THE INNER CANNULA AND REPLACED THE CAP, THE PATIENT'S STATUS RETURNED TO NORMAL. THE PATIENT WORKED FOR DECANNULATION.
Patient problems: Low Oxygen Saturation; Unintended Extubation
MAUDE report 16112974 ↗
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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