Shiley 6CN75RRecalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10884521205437), received between Aug 25, 2019 and Sep 4, 2026 — classified as 1 death, 13 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (52 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K150844); they may or may not involve this specific model.

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.

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Material Split, Cut or Torn

  It was reported that during a tracheostomy procedure, the trach tube's cuff was found to be punctured, rendering the tube unfit for proper use. A new one was opened to allow the procedure to continue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601518 ↗
• MalfunctionAug 8, 2026Gas/Air Leak

  It was reported that the tracheostomy tube had a rapid cuff air leak after 1 day of patient use. There was no patient harm.

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

  MAUDE report 50184601 ↗
• DeathJun 26, 2026Material Deformation

  IT WAS REPORTED THAT THE PATIENT HAD CARDIORESPIRATORY ARREST AFTER NOT BEING ABLE TO VENTILATE THROUGH THE TRACHEOSTOMY AND EXPIRED. DURING PLACEMENT OF THE TRACHEOSTOMY TUBE, IT BECAME ANGLED, WHICH MADE VENTILATION IMPOSSIBLE. THE PATIENT WAS NOT ON MECHANICAL VENTILATION AT THAT TIME. THE PATIENT WAS BEING ASSISTED WITH AN AMBU BAG. AFTER TEN MINUTES OF VENTILATORY DIFFICULTY, THE TUBE WAS REPLACED WITH SIMILAR ISSUES.

  Patient problems: Asystole; Cardiac Arrest; Unintended Extubation

  MAUDE report 25635107 ↗
• MalfunctionJun 25, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TRACH TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25628201 ↗
• MalfunctionJun 25, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TRACH TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627031 ↗
• MalfunctionJun 17, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE OF THE FIRST TRACHEOSTOMY TUBE AN ALARM WAS HEARD FROM THE VENTILATOR DUE TO HIGH LEAKS. IT WAS MENTIONED THAT THE PRESSURE OF THE CUFF WAS NEVER MEASURED DURING FILLING. TRIED TO FILL THE CUFF BUT DETERMINED TO CHANGE THE TUBE. THE CUFF OF THE SECOND AND THE THIRD TRACHEOSTOMY TUBE DEFLATED AND ON THE THIRD TRACHEOSTOMY TUBE THE PATIENT HAD DETERIORATION ON THE VENTILATION.

  Patient problems: Unintended Extubation

  MAUDE report 25536914 ↗
• MalfunctionJun 17, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE OF THE FIRST TRACHEOSTOMY TUBE AN ALARM WAS HEARD FROM THE VENTILATOR DUE TO HIGH LEAKS. IT WAS MENTIONED THAT THE PRESSURE OF THE CUFF WAS NEVER MEASURED DURING FILLING. TRIED TO FILL THE CUFF BUT DETERMINED TO CHANGE THE TUBE. THE CUFF OF THE SECOND AND THE THIRD TRACHEOSTOMY TUBE DEFLATED AND ON THE THIRD TRACHEOSTOMY TUBE THE PATIENT HAD DETERIORATION ON THE VENTILATION.

  Patient problems: Unintended Extubation

  MAUDE report 25536735 ↗
• MalfunctionMay 14, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE, THE CUFF OF THE TUBE HAD A LEAK. REPLACEMENT OF THE TUBE WAS DONE. PLI20: MEDTRONIC'S EVALUATION OF THE INCIDENT DEVICE FOUND IN A DIFFERENT LOT NUMBER RECEIVED AND SHOWED A CLEAN-CUT SLIT ON THE MAIN BODY OF THE CUFF.

  Patient problems: Insufficient Information

  MAUDE report 25176290 ↗
• MalfunctionMay 13, 2026Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE OF THE FIRST TRACHEOSTOMY TUBE AN ALARM WAS HEARD FROM THE VENTILATOR DUE TO HIGH LEAKS. IT WAS MENTIONED THAT THE PRESSURE OF THE CUFF WAS NEVER MEASURED DURING FILLING. TRIED TO FILL THE CUFF BUT DETERMINED TO CHANGE THE TUBE. THE SECOND AND THE THIRD TRACHEOSTOMY TUBE HAD CUFF DEFLATION AND INFLATION ISSUE AND ON THE THIRD TRACHEOSTOMY TUBE THE PATIENT HAD DETERIORATION ON THE VENTILATION.

  Patient problems: Unintended Extubation

  MAUDE report 25162556 ↗
• MalfunctionMay 13, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE OF THE FIRST TRACHEOSTOMY TUBE AN ALARM WAS HEARD FROM THE VENTILATOR DUE TO HIGH LEAKS. IT WAS MENTIONED THAT THE PRESSURE OF THE CUFF WAS NEVER MEASURED DURING FILLING. TRIED TO FILL THE CUFF BUT DETERMINED TO CHANGE THE TUBE. THE SECOND AND THE THIRD TRACHEOSTOMY TUBE HAD CUFF DEFLATION AND INFLATION ISSUE AND ON THE THIRD TRACHEOSTOMY TUBE THE PATIENT HAD DETERIORATION ON THE VENTILATION.

  Patient problems: Unintended Extubation

  MAUDE report 25162471 ↗
• MalfunctionMay 4, 2026Use of Device Problem

  IT WAS REPORTED THAT A TRACHEOSTOMY TUBE HAD AN AIR LEAK INVOLVING THE CUFF IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075202 ↗
• MalfunctionApr 17, 2026Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT UPON INFLATION OF THE TRACHEOSTOMY TUBE, IT WAS NOTED THAT THE CUFF WAS NOT RETAINING AIR. THE TUBE WAS REPLACED AND POST PROCEDURE STAFF NOTED A HOLE IN THE ORIGINAL BALLOON THAT WAS REMOVED.

  Patient problems: Unintended Extubation

  MAUDE report 24918084 ↗
• MalfunctionApr 15, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO TRACHEOSTOMY TUBE IMPLANTATION, THE CUFFS TO THE TWO TRACHEOSTOMY TUBE WERE CHECKED FOR LEAKAGE. THE CUFFS WERE INFLATED TO A PRESSURE OF 25 CMH2O AND PLACED IN NORMAL SALINE, WHERE BUBBLES WERE OBSERVED, INDICATING CUFF LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24891907 ↗
• MalfunctionApr 15, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO TRACHEOSTOMY TUBE IMPLANTATION, THE CUFFS TO THE TWO TRACHEOSTOMY TUBE WERE CHECKED FOR LEAKAGE. THE CUFFS WERE INFLATED TO A PRESSURE OF 25 CMH2O AND PLACED IN NORMAL SALINE, WHERE BUBBLES WERE OBSERVED, INDICATING CUFF LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24891896 ↗
• MalfunctionApr 13, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUFFS OF THE TWO TRACHEOSTOMY TUBE HAD AN AIR LEAK DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867831 ↗
• MalfunctionApr 13, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUFFS OF THE TWO TRACHEOSTOMY TUBE HAD AN AIR LEAK DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867829 ↗
• MalfunctionApr 8, 2026Use of Device Problem

  IT WAS REPORTED THAT WHILE PLACING THE PATIENT ON A VENTILATOR, THE PILOT BALLOON WAS NOT HOLDING AIR AND CONTAINED MOISTURE. AFTER REMOVAL AIR IMMEDIATELY LEAKED OUT. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24824376 ↗
• MalfunctionMar 31, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING CHRONIC HOME VENTILATION, THE TRACHEOSTOMY TUBE'S CUFF WAS ASSOCIATED WITH A LEAK NOTICED BY BOTH THE VENTILATOR AND THE PATIENT. THE PATIENT WAS VERY SENSITIVE TO LEAKS AND THE LEAK WAS DISCOVERED A FEW DAYS AFTER INSTALLATION AND IT WAS NOTED THAT THE PATIENT'S FAMILY MAY HAVE BEEN INFLATING THE CUFF DAILY. THE TUBE WAS REPLACED TO RESOLVED THE ISSUE.

  Patient problems: Unintended Extubation

  MAUDE report 24749555 ↗
• MalfunctionMar 25, 2026Use of Device Problem

  IT WAS REPORTED THAT AT A HOMECARE CENTER, THE TRACHEOSTOMY TUBE'S CUFF WAS DIFFICULT TO INFLATE DURING THE PRE-TEST. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691597 ↗
• MalfunctionMar 23, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING CHRONIC HOME VENTILATION, THE TRACHEOSTOMY TUBE'S CUFF WAS ASSOCIATED WITH A LEAK NOTICED BY BOTH THE VENTILATOR AND THE PATIENT. THE PATIENT WAS VERY SENSITIVE TO LEAKS AND THE LEAK WAS DISCOVERED A FEW DAYS AFTER INSTALLATION AND IT WAS NOTED THAT THE PATIENT'S FAMILY MAY HAVE BEEN INFLATING THE CUFF DAILY. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24669609 ↗
• MalfunctionMar 12, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF DID NOT INFLATE DURING USE. THE ISSUE TOOK PLACE IN A HOSPITAL SETTING AND THE TUBE WAS REPLACED TO RESOLVED THE ISSUE.

  Patient problems: Unintended Extubation

  MAUDE report 24582433 ↗
• InjuryFeb 19, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF WAS CHECKED PRIOR TO INSERTION AND FOUND TO BE NOT FAULTY, HOWEVER IT LOST AIR AFTER INSERTION. AN ET TUBE WAS PUT INTO PLACE WHILE WAITING FOR A BACKUP TUBE, HOWEVER THE PATIENT THEN WENT INTO CARDIAC ARREST WHICH WAS NOT DEVICE RELATED. THERE WERE OTHER SIGNIFICANT ISSUES WITH THE PATIENT¿S AIRWAY WHICH CONTRIBUTED TO THE CPR INCIDENT. THE TUBE WAS REPLACED.

  Patient problems: Cardiac Arrest; Insufficient Information; Unintended Extubation

  MAUDE report 24387335 ↗
• MalfunctionFeb 16, 2026Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF WAS PERFORATED AND COULD NOT BE INFLATED AS SHOWN FROM THE VIDEO, DURING PRE-USE TESTING AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24347169 ↗
• MalfunctionFeb 16, 2026Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF WAS PERFORATED AND COULD NOT BE INFLATED AS SHOWN FROM THE VIDEO, DURING PRE-USE TESTING AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24347098 ↗
• MalfunctionJan 28, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE THREE TRACHEOSTOMY TUBES DID NOT HOLD THE PRESSURE. THEY WERE INFLATED AND DEFLATED SOON AFTER. DID A FIBROLARYNGOSCOPY TO SEE IF THERE WERE ANY GROWTHS THAT COULD BLOCK THE CUFF BUT NOTHING. ANOTHER TUBE OF THE SAME LOT DID NOT CAUSED ANY PROBLEMS.

  Patient problems: Unintended Extubation

  MAUDE report 24206034 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150844. One submission often covers many models, so check the product and lot details in each record.

• Z-1390-2025 · Feb 26, 2025 · Open, Classified
  Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R