Shiley 5CN70ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521172463), received between Aug 28, 2019 and Aug 25, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (6 reports).

1 FDA recall record name this device's identifier, 1 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE TRACHEOSTOMY TUBE'S CUFF HAD A LEAK. THE TUBE HAS BEEN INFLATED SEVERAL TIMES BEFORE IT WAS REPLACED. THE PATIENT WAS ALSO STATED TO HAVE EXPERIENCED DISCOMFORT.

  Patient problems: Discomfort; Unintended Extubation

  MAUDE report 20061055 ↗
• InjuryAug 24, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE TRACHEOSTOMY TUBE'S CUFF HAD A LEAK. THE TUBE HAS BEEN INFLATED SEVERAL TIMES BEFORE IT WAS REPLACED. THE PATIENT WAS ALSO STATED TO HAVE EXPERIENCED DISCOMFORT.

  Patient problems: Discomfort; Unintended Extubation

  MAUDE report 20058314 ↗
• MalfunctionAug 22, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE TRACHEOSTOMY TUBE'S CUFF HAD A LEAK BASED ON THE VIDEO PROVIDED. IT WAS ALSO THE THIRD INSTANCE IN A SHORT TIME THAT THE CUFF WAS LEAKING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20028712 ↗
• MalfunctionFeb 8, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DOCTOR CAME TO REPLACE THE OLD UNIT WHEN THE FAMILY SPOTTED THREE THINGS FOLLOWING THE REPLACEMENT. ONE WAS A LEAK FROM THE VENTILATOR, WHICH NORMALLY HAD VT OF 500-550 WHERE POST-INSERTION OF THE TRACH DROPPED IT TO VT OF 200-250. IN ADDITION, THE NURSE CHECKED THE PILOT BALLOON, AND IT SEEMED THE CUFF WAS EMPTY. ALSO, THE PATIENT EXPERIENCED GRUNTING NOISES (RESPIRATION). THE FAMILY INFLATED THE CUFF EVERY 2-3 HOURS. THE DOCTOR REPLACED THE CANNULA WITH ONE OF THE SAME LOT. BEFORE INSERTING THE TRACH, THE DOCTOR PRE-TESTED THE CUFF TO SEE IF IT WAS WORKING PROPERLY, AND SO IT DID. AND AGAIN, 3-4 HOURS LATER, THE ISSUE OF LEAKS AND SYMPTOMS APPEARED AS IF THE CUFF HAD BEEN DEFLATED AGAIN. THE PATIENT STATED THAT WITH THE TRACH, THERE WAS DIFFICULTY BREATHING. THE DEVICE WAS REPLACED WITH A DIFFERENT DEVICE WITH NO FURTHER ISSUES.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 13487396 ↗
• InjuryFeb 8, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DOCTOR CAME TO REPLACE THE OLD UNIT WHEN THE PATIENT'S RELATIVE REPORTED THREE THINGS; LEAK FROM THE VENTILATOR, WHICH NORMALLY HAD VT OF 500-550, AND WITH THE POST-INSERTION OF THE TRACH IT DROPPED TO VT OF 200-250. IN ADDITION, THE NURSE HAS CHECKED THE PILOT BALLOON, AND IT SEEMED THE CUFF WAS EMPTY. ALSO, THE PATIENT EXPERIENCED GRUNTING NOISES (RESPIRATION). THE PATIENT'S RELATIVE HAS INFLATED THE CUFF EVERY 2-3 HOURS. THE DOCTOR HAS REPLACED THE CANNULA WITH THE SAME ONE (SAME LOT), YET BEFORE INSERTING THE TRACH, HE HAS PRE-TESTED THE CUFF, AND IT WAS WORKING PROPERLY. 3-4 HOURS LATER, THE ISSUE OF LEAKS AND SYMPTOMS APPEARED AS IF THE CUFF HAD BEEN DEFLATED AGAIN. THE PATIENT STATED THAT WITH THE NEW TRACH, THERE WAS DIFFICULTY BREATHING.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 13487281 ↗
• MalfunctionFeb 8, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF ISSUE WAS RAISED AGAIN. ON THAT SAME EVENING, THE UNIT WAS REPLACED WITH THE OLD TYPE THAT WAS USED PRIOR. THE PATIENT EXPLAINED THAT WITH THE NEW TRACH THERE WERE DIFFICULTIES IN BREATHING.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 13486406 ↗
• MalfunctionAug 28, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, UPON OPENING THE BOX, THERE WAS A HOLE IN THE CUFF PART. IT WAS REPORTED THAT IT WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8938551 ↗