Shiley 7CN80EDRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521726222), received between Jul 21, 2021 and Aug 6, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (12 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Use of Device Problem

  Patient problems: Unintended Extubation

  MAUDE report 50168294 ↗
• MalfunctionJul 10, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785011 ↗
• MalfunctionMar 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING USE. THE TRACHEOSTOMY TUBE LOSES PRESSURE; THIS WAS OBSERVED OVER SEVERAL PERIODS AND NIGHTS. THE BALLOON PRESSURE DROPS FROM 30 CM H2O TO APPROXIMATELY 14 CM H2O WITHIN 2 TO 3 HOURS. IT SHOULD BE NOTED THAT THE PATIENT OFTEN COUGHS VERY FORCEFULLY. THE SAME PROBLEM PERSISTS AFTER CHANGING THE TRACHEOSTOMY TUBE. THE CAUSE DOES NOT APPEAR TO BE FROM THE BALLOON/CUFF, BUT RATHER THE VALVE. THE VALVE WAS BLOCKED AND PREVENTED PRESSURE LOSS.

  Patient problems: Unintended Extubation

  MAUDE report 24552147 ↗
• MalfunctionMar 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING USE THE TRACHEOSTOMY TUBE LOSES PRESSURE. THIS WAS OBSERVED OVER SEVERAL PERIODS AND NIGHTS. THE BALLOON PRESSURE DROPS FROM 30 CM H2O TO APPROXIMATELY 14 CM H2O WITHIN 2 TO 3 HOURS. IT SHOULD BE NOTED THAT THE PATIENT OFTEN COUGHS VERY FORCEFULLY. THE SAME PROBLEM PERSISTS AFTER CHANGING THE TRACHEOSTOMY TUBE. THE CAUSE DOES NOT APPEAR TO BE FROM THE BALLOON/CUFF, BUT RATHER THE VALVE. THE VALVE WAS BLOCKED AND PREVENTED PRESSURE LOSS.

  Patient problems: Unintended Extubation

  MAUDE report 24552073 ↗
• MalfunctionSep 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080903 ↗
• MalfunctionSep 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080898 ↗
• MalfunctionSep 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080883 ↗
• MalfunctionApr 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF TRACHEOSTOMY TUBE COULD NOT BE USED BECAUSE IT WAS DEFLATED. AFTER REMOVAL, IT WAS CONFIRMED THAT THERE WERE NO PINHOLE IN THE CUFF AND THAT THERE WAS NO PROBLEM. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21766274 ↗
• MalfunctionMar 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF TRACHEOSTOMY TUBE COULD NOT BE USED BECAUSE IT WAS DEFLATED. AFTER REMOVAL, IT WAS CONFIRMED THAT THERE WERE NO PINHOLE IN THE CUFF AND THAT THERE WAS NO PROBLEM. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21643104 ↗
• MalfunctionMar 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS TRACHEOSTOMY TUBES COULD NOT BE USED BECAUSE THEY WERE DEFLATED. AFTER REMOVAL, IT WAS CONFIRMED THAT THERE WERE NO PINHOLES IN THE CUFF AND THERE WAS NO PROBLEM.

  Patient problems: Unintended Extubation

  MAUDE report 21643074 ↗
• MalfunctionJun 14, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19541325 ↗
• MalfunctionJun 7, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS AN AIR LEAK IN THE CUFF OF THE TRACHEOSTOMY TUBE. AN EMERGENCY CHANGE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19490564 ↗
• MalfunctionJan 5, 2024Crack; Use of Device Problem; Crack; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAS BEEN CLEANED AT THE FACILITY, BUT THERE WAS SOME SLIGHT ADHESION AND A CRACK WAS OBSERVED IN THE INNER CANNULA. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 18450173 ↗
• MalfunctionJul 21, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE PILOT BALLOON HAD A BREAKAGE AND DEFLATED WHEN TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206913 ↗
• MalfunctionJul 21, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE PILOT BALLOON HAD A BREAKAGE AND DEFLATED WHEN TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204629 ↗
• MalfunctionJul 21, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE PILOT BALLOON HAD A BREAKAGE AND DEFLATED WHEN TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202794 ↗
• MalfunctionJul 21, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE PILOT BALLOON HAD A BREAKAGE AND DEFLATED WHEN TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202746 ↗