Shiley 3.0PCF (UDI 10884521103511)Recalls & reported problems
Covidien LP · Pediatric 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521103511), received between Apr 11, 2021 and Apr 11, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Gas/Air Leak” (1 report).
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 Leak1
Patient problems
- Unintended Extubation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2021Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE CUFF HAD AN INFLATION/DEFLATION ISSUE. THE AIR WAS EVACUATED USING 2 ML SYRINGE AFTER TWO TO THREE MINUTES AND THE DEVICE SLOWLY RE-INFLATED AND PULSATED WITH BREATHING. THE SPRING ENGAGED AND SPRINGS WERE BACK, BUT THERE MUST BE A LEAK. THE PATIENT HAD A HISTORY OF CONGENITAL CENTRAL HYPOVENTILATION SYNDROME. IT WAS INDICATED THAT THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 11646882 ↗
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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