Shiley 5.0PLCF (UDI 10884521103573)Recalls & reported problems
Covidien LP · Pediatric Tracheostomy Tube Long with TaperGuard Cuff · 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 10884521103573), received between Jun 9, 2023 and Jan 5, 2024 — classified as 4 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak2
- Material Split, Cut or Torn2
- Obstruction of Flow1
- Use of Device Problem1
Patient problems
- Unintended Extubation4
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE INFLATION LINE OF THE TRACHEOSTOMY TUBE WAS DAMAGED AND REMOVED FROM THE PROXIMAL SIDE DURING NORMAL USE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 18461040 ↗MalfunctionJun 12, 2023Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE TRACH'S CUFF HAD A CRACK AND DID NOT INFLATE AFTER A WEEK OF PATIENT USE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.
Patient problems: Insufficient Information; Unintended Extubation
MAUDE report 17109996 ↗MalfunctionJun 12, 2023Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE TRACH'S CUFF HAD A CRACK AND DID NOT INFLATE AFTER 19 DAYS OF PATIENT USE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 17109964 ↗MalfunctionJun 9, 2023Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE REPORTER, THE TRACH'S LUMEN TUBE BECAME CLOGGED WITH SECRETIONS AFTER THREE DAYS OF USE AND GOT REPLACED WITH AN OLD TYPE.
Patient problems: Unintended Extubation
MAUDE report 17100589 ↗
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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