Shiley 5CN70ERRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521726277), received between Dec 8, 2022 and Sep 29, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (13 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941085 ↗
• MalfunctionApr 20, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TRACH TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925785 ↗
• MalfunctionApr 1, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACH TUBE'S CUFF WAS LEAKING AIR FOR SEVEN DAYS OF PATIENT USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24753674 ↗
• MalfunctionMar 31, 2026Gas/Air Leak

  IT WAS REPORTED THAT AFTER 3 DAYS OF PATIENT USAGE, THE CUFF OF THE TRACHEOSTOMY TUBE KEPT LEAKING AIR. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24750292 ↗
• MalfunctionMar 24, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE LEAKED AIR AFTER 9 DAYS OF PATIENT USED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24678439 ↗
• MalfunctionAug 26, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF WAS UNABLE TO INFLATE PROPERLY WHILE PUT ONTO PATIENT. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22898820 ↗
• MalfunctionJul 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF DID NOT MAINTAIN INTERNAL PRESSURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507744 ↗
• MalfunctionApr 1, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK AFTER FIRST DAY OF PATIENT USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21746507 ↗
• MalfunctionJan 31, 2025Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn; Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBES HAD ISSUES WITH THE CUFFS NOT HOLDING AND AIR WAS GOING OUTSIDE THE PILOT BALLOONS, NECESSITATING THE TUBE TO BE BLOCKED AGAIN. REPLACEMENT OF THE TUBE WAS DONE.

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

  MAUDE report 21280591 ↗
• MalfunctionJan 31, 2025Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn; Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBES HAD ISSUES WITH THE CUFFS NOT HOLDING AND AIR WAS GOING OUTSIDE THE PILOT BALLOONS, NECESSITATING THE TUBE TO BE BLOCKED AGAIN. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21280589 ↗
• MalfunctionJan 30, 2025Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn; Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBES HAD ISSUES WITH THE CUFFS NOT HOLDING AND AIR WAS GOING OUTSIDE THE PILOT BALLOONS, NECESSITATING THE TUBE TO BE BLOCKED AGAIN. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21280565 ↗
• MalfunctionJan 30, 2025Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn; Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOUR TRACHEOSTOMY TUBES HAD AN ISSUE WITH ITS CUFF NOT HOLDING AIR AND GOING OUTSIDE THE PILOT BALLOON DURING TESTING, PRIOR TO USAGE ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21280520 ↗
• MalfunctionDec 15, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS LEAKING AND PILOT BALLOON WAS FOUND CRACKED. THERE WAS NO PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 15992091 ↗
• MalfunctionDec 15, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS LEAKING AND PILOT BALLOON WAS FOUND CRACKED. THERE WAS NO PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 15991894 ↗
• MalfunctionDec 12, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS LEAKING AND PILOT BALLOON WAS FOUND CRACKED. THERE WAS NO PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 15960504 ↗
• MalfunctionDec 8, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF WAS TESTED PRIOR TO USE WITH A SYRINGE BUT DURING USE THE CUFF HAD A LEAK. THERE WAS A REQUIRED TUBE REPLACEMENT WITH A LARGER SIZE.

  Patient problems: Unintended Extubation

  MAUDE report 15947261 ↗