Shiley 7CN80ERRecalls & reported problems
Covidien LP · Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula · Class 2
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884521726291), received between Jun 7, 2024 and Sep 24, 2026 — classified as 2 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (21 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak21
- Use of Device Problem4
- Material Split, Cut or Torn1
- Mechanical Problem1
Patient problems
- Unintended Extubation22
- No Clinical Signs, Symptoms or Conditions4
- Hypoventilation2
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50891961 ↗MalfunctionSep 24, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50891939 ↗MalfunctionSep 24, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50890060 ↗MalfunctionAug 26, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50464513 ↗MalfunctionAug 25, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50437666 ↗MalfunctionJul 13, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 25802692 ↗MalfunctionApr 8, 2026Use of Device Problem; Gas/Air Leak
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD A CUFF INFLATION AND DEFLATION ISSUE IDENTIFIED AT A HOSPITAL. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 24821013 ↗MalfunctionDec 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS USED, AND A LEAKAGE ISSUE WAS IDENTIFIED BY THE NURSE MANAGER. THE LEAKAGE WAS MINIMAL AT THAT TIME. MONITORING WAS CONTINUED TO ENSURE THAT THE CUFF REMAINS PROPERLY INFLATED AND EFFORTS WERE MADE TO AVOID REPLACING THE TRACHEOTOMY TUBE TO PREVENT THE PATIENT FROM EXPERIENCING THE DISCOMFORT ASSOCIATED WITH ANOTHER TUBE CHANGE. THE TUBE WAS SUBSEQUENTLY REPLACED FROM A DIFFERENT MANUFACTURER. THE TRACHEOSTOMY TUBE WAS FOUND TO HAVE A SMALL BROKEN CUFF BALLOON.
Patient problems: Unintended Extubation
MAUDE report 23782930 ↗MalfunctionDec 3, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF HAD AN AIR LEAKED RAPIDLY ON THE FIRST DAY OF PATIENT USE. THE ISSUE OCCURRED IN A HOSPITAL SETTING, AND THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23709029 ↗MalfunctionNov 20, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF LEAKED ON THE FIRST DAY OF PATIENT USED. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23606418 ↗MalfunctionSep 15, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE LEAK AIR RAPIDLY ON THE FIRST DAY OF PATIENT USE. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 23059170 ↗MalfunctionSep 11, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS UNABLE TO BE INFLATED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23034153 ↗MalfunctionSep 11, 2025Mechanical Problem; Gas/Air Leak; Mechanical Problem; Gas/Air Leak
IT WAS REPORTED THAT A PATIENT USING THE TRACHEOSTOMY TUBE CANNULA AT HOME EXPERIENCED DIFFICULTY SUCTIONING SECRETIONS WITH A SYRINGE AND FELT THAT THE CUFF WAS NOT MAINTAINING ADEQUATE PRESSURE. IT WAS MENTIONED THAT THERE WAS NO OBSTRUCTION OR OCCLUSION IDENTIFIED. THE CUFF WAS TESTED PRIOR TO USE WITH 10CC OF AIR. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 23034147 ↗MalfunctionAug 7, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD AN AIR LEAK AFTER 4 DAYS OF BEING USE. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 22745793 ↗MalfunctionAug 7, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE CUFF CONNECTED TO THE MAIN TUBE OF THE TRACHEOSTOMY TUBE DEVELOPED AN AIR LEAK AFTER 16 DAYS OF PATIENT USE IN A HOSPITAL SETTING. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22735160 ↗MalfunctionAug 5, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak
IT WAS REPORTED THAT THE TRACH TUBE'S CUFF HAD AN AIR LEAK AFTER TEN DAYS OF PATIENT USE. AFTER THE REMOVAL OF THE TUBE, THE PILOT LINE WAS DETACHED FROM THE TUBE AS SHOWN IN THE IMAGE ATTACHED. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22715818 ↗MalfunctionJul 26, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE TRACH TUBE'S CUFF HAD AN AUR LEAK AFTER SEVEN DAYS OF PATIENT USE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22621599 ↗MalfunctionJul 25, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE TRACH TUBE'S CUFF HAD AN AUR LEAK AFTER FOURTEEN DAYS OF PATIENT USE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22613633 ↗MalfunctionJul 25, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE TRACH TUBE'S CUFF HAD AN AUR LEAK AFTER TEN DAYS OF PATIENT USE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22613608 ↗MalfunctionJun 5, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE CUFF OF THE 8.MM TRACHEOSTOMY TUBE WAS FOUND LEAKING BASED ON THE VIDEO PROVIDED, AFTER 20 DAYS OF PATIENT USE IN A HOSPITAL SETTING. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22154204 ↗MalfunctionFeb 19, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THERE WAS A CUFF INFLATION AND DEFLATION ISSUE WITH THE 8.0MM TRACHEOSTOMY TUBE AT A HOSPITAL. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407236 ↗InjuryJul 11, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, BOTH OF THE TRACHEOSTOMY TUBES' CUFFS HAD AIR LEAKS WHICH CAUSED VENTILATOR LOW VOLUME ALARM. THE TUBES WERE REPLACED.
Patient problems: Hypoventilation; Unintended Extubation
MAUDE report 19725765 ↗InjuryJul 11, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, BOTH OF THE TRACHEOSTOMY TUBES' CUFFS HAD AIR LEAKS WHICH CAUSED VENTILATOR LOW VOLUME ALARM. THE TUBES WERE REPLACED.
Patient problems: Hypoventilation; Unintended Extubation
MAUDE report 19724336 ↗MalfunctionJun 7, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, BOTH TRACHEOSTOMY TUBES' CUFF HAD A LEAK DURING PATIENT USAGE. THE TUBES WERE REPLACED.
Patient problems: Unintended Extubation
MAUDE report 19487481 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.