Shiley 6CN75ARecalls & reported problems
Covidien LP · Adult Flexible Tracheostomy Tube with TaperGuard Cuff Disposable Inner Cannula · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Shiley tracheostomy tube is a flexible breathing tube with a cuff and disposable inner cannula for adults. The 42 reports that name its identifier mostly describe cuff leaks or tears and loose connections, sometimes mentioning the tube coming out and low oxygen. The reports mention no deaths and 9 injuries. It has 1 open recall from March 2023 about connectors made too narrow to hold circuit parts securely.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10884521172470), received between Feb 15, 2019 and Sep 15, 2026 — classified as 9 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (21 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Use of Device Problem21
- Gas/Air Leak11
- Material Split, Cut or Torn8
- Disconnection3
- Break2
- Connection Problem2
- Defective Component2
- Labelling, Instructions for Use or Training Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Unintended Extubation14
- Extubate6
- Low Oxygen Saturation3
- Insufficient Information2
- Asystole1
- Dyspnea1
- Hypoventilation1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Use of Device Problem
It was reported that the time of tracheostomy tube insertion, the cuff "burst" after inflation with 2 or 3 mil air. Another tube was immediately inserted without incident.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774334 ↗MalfunctionSep 14, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50764189 ↗MalfunctionSep 14, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50763632 ↗MalfunctionSep 14, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50763333 ↗MalfunctionSep 4, 2026Use of Device Problem
It was reported that during pre-usage inspection, it was found that the trach tube's cuff won't inflate, as shown in the attached video. A new trach was used instead. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50601727 ↗MalfunctionAug 30, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50510314 ↗MalfunctionAug 30, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50510313 ↗MalfunctionAug 19, 2026Use of Device Problem
Patient problems: Unintended Extubation
MAUDE report 50330332 ↗MalfunctionJul 28, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50056073 ↗MalfunctionJul 28, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50056013 ↗MalfunctionJun 22, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, IT WAS FOUND THAT THE TRACH TUBE'S CUFF WAS LEAKING AND THE DEVICE COULD NOT BE USED NORMALLY. A NEW TRACHEOSTOMY TUBE WAS IMMEDIATELY REPLACED, AND NO FURTHER LEAKAGE WAS OBSERVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25576750 ↗InjuryMay 6, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE PATIENT WAS DESATURATING AND TACHYCARDIC, AND UPON DEFLATING THE TRACHEOSTOMY TUBE'S CUFF; 2CC OF SECRETIONS WERE OBTAINED. THE TUBE WAS CHANGED AND UPON VISUAL EXAMINATION, THE CUFF WAS FOUND TO BE PERFORATED.
Patient problems: Low Oxygen Saturation; Tachycardia; Unintended Extubation
MAUDE report 25106217 ↗MalfunctionMar 18, 2026Gas/Air Leak; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING USE, THERE WERE LEAKS IN THE CUFF, WHICH OCCURRED SEVERAL HOURS AFTER INSTALLATION. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 24634104 ↗MalfunctionFeb 23, 2026Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THERE WERE LEAKS IN THE CUFF, WHICH OCCURRED SEVERAL HOURS AFTER INSTALLATION. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information; Unintended Extubation
MAUDE report 24423747 ↗MalfunctionFeb 13, 2026Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF HAD LEAKS. THE TUBE WAS REPLACED. THE SITUATION MAY BE RELATED TO AN INAPPROPRIATE TRACHEOSTOMY TUBE SIZE SELECTION FOR A PATIENT WITH OBESITY.
Patient problems: Unintended Extubation
MAUDE report 24336181 ↗MalfunctionDec 19, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT CUFFS OF THE TRACHEOSTOMY TUBES INFLATED WHEN TESTED, ONCE PUT INTO PATIENT WOULD NOT INFLATE. IT WAS MENTIONED ON THE REPORT THAT THERE WAS A DELAYED ON PROCEDURE BUT NO HARM ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIRD TUBE.
Patient problems: Unintended Extubation
MAUDE report 23848681 ↗MalfunctionDec 12, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT CUFFS OF THE TRACHEOSTOMY TUBES INFLATED WHEN TESTED, ONCE PUT INTO PATIENT WOULD NOT INFLATE. IT WAS MENTIONED ON THE REPORT THAT THERE WAS A DELAYED ON PROCEDURE BUT NO HARM ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIRD TUBE.
Patient problems: Unintended Extubation
MAUDE report 23796896 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING THE PREOPERATIVE INFLATION TEST OF THE TRACHEOSTOMY TUBE, AN AIR LEAK WAS DETECTED IN THE CUFF. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23020033 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING THE PREOPERATIVE INFLATION TEST OF THE TRACHEOSTOMY TUBE, AN AIR LEAK WAS DETECTED IN THE CUFF. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019844 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING THE PREOPERATIVE INFLATION TEST OF THE TRACHEOSTOMY TUBE; AN AIR LEAK WAS DETECTED IN THE CUFF. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019775 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING THE PREOPERATIVE INFLATION TEST OF THE TRACHEOSTOMY TUBE, AN AIR LEAK WAS DETECTED IN THE CUFF. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019770 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING THE PREOPERATIVE INFLATION TEST OF THE TRACHEOSTOMY TUBE; AN AIR LEAK WAS DETECTED IN THE CUFF. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019753 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING THE PREOPERATIVE INFLATION TEST OF THE TRACHEOSTOMY TUBE, AN AIR LEAK WAS DETECTED IN THE CUFF. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019746 ↗MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING THE PREOPERATIVE INFLATION TEST OF THE TRACHEOSTOMY TUBE, AN AIR LEAK WAS DETECTED IN THE CUFF. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019714 ↗MalfunctionAug 26, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING PRE-TEST INSPECTION, BOTH TRACHEOSTOMY TUBE'S CUFF HAD AIR LEAKS AFTER INFLATING AND PLACED IN NORMAL SALINE WHEREIN BUBBLES WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20070140 ↗
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- Bivona 670170Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall10 deaths132 reports
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- Bivona 67PFSS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall115 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.