Shiley 7IC80Recalls & reported problems
Covidien LP · Disposable 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 10884521511941), received between Aug 24, 2026 and Sep 3, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 reports).
1 other recall cover devices cleared under the same FDA submission (K142296); they may or may not involve this specific model.
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 Split, Cut or Torn4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Material Split, Cut or Torn
It was reported that during use, the trach tube inner cannula had a split on the side after a few days of use. There was no need to change the whole tracheostomy tube, only the inner cannula There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50579186 ↗MalfunctionAug 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416316 ↗MalfunctionAug 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50415945 ↗MalfunctionAug 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50415254 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142296. One submission often covers many models, so check the product and lot details in each record.
- Z-1357-2023 · Mar 24, 2023 · Open, ClassifiedShiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CU
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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