Shiley 9CN90ERRecalls & reported problems
Covidien LP · Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula · Class 2
All models of Shiley (387)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521726314), received between Jan 26, 2023 and Apr 28, 2025 — classified as 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
- Material Split, Cut or Torn1
- Use of Device Problem1
Patient problems
- Unintended Extubation4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2025Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING THE USE OF THE 9.0MM TRACHEOSTOMY TUBE, THERE WAS A CUFF INFLATION OR DEFLATION ISSUE. THE DEFECTIVE CANNULA WAS REPLACED AND THE ISSUE OCCURRED AT HOME.
Patient problems: Unintended Extubation
MAUDE report 21922787 ↗MalfunctionMay 1, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF DID NOT MAINTAIN PRESSURE EVEN WHEN TRIED TO PLACE A CAP/BUNG ON THE PILOT DURING THE PROCEDURE. THE TRACH WAS REPLACED. IT WAS STATED THAT THE REMOVED TRACH HAD A SPLIT IN THE CUFF THAT COULD BE SEEN, AND DID NOT FULLY INFLATE WHEN TRIED TO BE INFLATED.
Patient problems: Unintended Extubation
MAUDE report 19219097 ↗MalfunctionJan 26, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE TUBES WERE NOT WORKING. THE UNITS WERE INFLATED, BUT THE CUFFS WOULD NOT WORK AS IT KEPT LOOSING AIR. THERE WAS A REQUIRED TUBE REPLACEMENT.
Patient problems: Unintended Extubation
MAUDE report 16246673 ↗MalfunctionJan 26, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE TUBES WERE NOT WORKING. THE UNITS WERE INFLATED, BUT THE CUFFS WOULD NOT WORK AS IT KEPT LOOSING AIR. THERE WAS A REQUIRED TUBE REPLACEMENT.
Patient problems: Unintended Extubation
MAUDE report 16246559 ↗
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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