Shiley 7CN80RRecalls & reported problems

Summary

The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 10884521205444), received between Oct 19, 2021 and Sep 16, 2026 — classified as 6 injuries, 142 malfunctions.

The most frequently reported specific device problem is “Disconnection” (88 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Feb 26, 2025Open, Classified

   Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.

   Z-1390-2025 · Root cause: Under Investigation by firm · FDA record ↗

2. Mar 24, 2023Open, Classified

   A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.

   Z-1357-2023 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 148 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793770 ↗
• MalfunctionJul 31, 2026Gas/Air Leak

  Patient problems: Unintended Extubation

  MAUDE report 50098919 ↗
• MalfunctionJul 17, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25854405 ↗
• MalfunctionJul 17, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25854294 ↗
• MalfunctionJul 17, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25854224 ↗
• MalfunctionJul 17, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25854132 ↗
• MalfunctionJul 13, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25806234 ↗
• MalfunctionMay 15, 2026Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD A PILOT BALLOON DYSFUNCTION DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 25191552 ↗
• MalfunctionMar 12, 2026Use of Device Problem

  IT WAS REPORTED THAT, PRIOR TO USE, THE CUFF OF THE TRACHEOSTOMY TUBE LEAKED AIR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586816 ↗
• MalfunctionFeb 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING THE SCHEDULED EXCHANGE OF A TRACHEOSTOMY CANNULA, A CUFF DEFECT WAS OBSERVED AFTER THE CANNULA CHANGED AS IT DID NOT INFLATE. THE ISSUE WAS IDENTIFIED IN THE HOSPITAL SETTING, AND THE PATIENT WAS TREATED BY REPLACING THE CANNULA.

  Patient problems: Unintended Extubation

  MAUDE report 24309243 ↗
• MalfunctionFeb 9, 2026Disconnection

  IT WAS REPORTED THAT AFTER POSITIONING THE PATIENT, THE STAFF NOTICED LEAKAGE AROUND TRACHEOSTOMY. IT WAS FOUND THAT THE FLANGE SEPARATED FROM THE SITE. THE DOCTOR REMOVED THE INNER CANULA, INSERTED ANOTHER AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299009 ↗
• MalfunctionDec 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE THREE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK DURING PRE-USE TESTING IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824751 ↗
• MalfunctionDec 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE THREE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK DURING PRE-USE TESTING IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824745 ↗
• MalfunctionDec 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE THREE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK DURING PRE-USE TESTING IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824739 ↗
• MalfunctionDec 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY CANNULA'S CUFF DID NOT REMAIN INFLATED, NECESSITATING A CHANGE OF THE CANNULA. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735249 ↗
• MalfunctionNov 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT TWO TRACHEOSTOMY TUBES EXPERIENCED CUFF AIR LEAKS DURING USE IN A HOSPITAL SETTING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575795 ↗
• MalfunctionNov 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TWO CUFFS OF THE TRACHEOSTOMY TUBES LEAKED AIR WHEN CHECKED BEFORE INSERTION. WHEN INFLATED THE CUFF TO A PRESSURE OF 25 CM H2O AND IMMERSED IN NORMAL SALINE, BUBBLES WERE OBSERVED, INDICATING AIR LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444717 ↗
• MalfunctionNov 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TWO CUFF OF THE TRACHEOSTOMY TUBES LEAKED AIR WHEN CHECKED BEFORE INSERTION. WHEN INFLATED THE CUFF TO A PRESSURE OF 25 CMH2O AND IMMERSED IN NORMAL SALINE, BUBBLES WERE OBSERVED, INDICATING AIR LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444692 ↗
• MalfunctionSep 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE OF THE TRACHEOSTOMY TUBE, THE CUFF HAD AN INFLATION AND DEFLATION. THE EVENT OCCURRED IN A HOSPITAL SETTING. THE CANNULA WAS REPLACED THE SAME DAY AND THERE WAS NO PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 23030538 ↗
• MalfunctionAug 21, 2025Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858498 ↗
• MalfunctionAug 21, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFFS OF THE TRACHEAL TUBES HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858468 ↗
• MalfunctionAug 7, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF FAILED TO INFLATE DURING PRE-USE TESTING AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738984 ↗
• MalfunctionJul 16, 2025Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE "RUPTURED" AFTER PUMPING DURING TESTING. REPLACEMENT OF THE TUBE WAS DONE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527439 ↗
• MalfunctionJul 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE HAD INFLATION AND DEFLATION ISSUES PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487768 ↗
• MalfunctionJul 8, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE EXPERIENCED RAPID AIR LEAKAGE AFTER ONE DAY OF PATIENT USE IN A HOSPITAL SETTING. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 22448635 ↗