Shiley 6CN75ERRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521726284), received between Oct 17, 2023 and Sep 23, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Obstruction of Flow

  It was reported that secretions could not be effectively aspirated through the subglottic suction line of the tracheostomy tube. The patient coughed up secretions after cuff deflation and the secretions were white in color and ranged from thin to slightly viscous in consistency. The tube was replaced.

  Patient problems: Unintended Extubation

  MAUDE report 50876187 ↗
• MalfunctionAug 25, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437756 ↗
• MalfunctionJun 9, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF OF THE TRACHEOSTOMY TUBE LEAKED AIR AFTER 1 DAY OF PATIENT USED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 25445546 ↗
• MalfunctionApr 6, 2026Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING PREPARATION, THE TRACHEOSTOMY TUBE'S STYLET WAS NOT SEALED DURING THE INSERTION AND THE GUIDEWIRE EXITED FROM THE BASE OF THE STYLET INSTEAD OF THROUGH THE DESIGNATED OPENINGS. IT WAS FURTHER REPORTED THAT IT WAS NOT POSSIBLE TO MAINTAIN THE STYLET SEAL DESPITE INSERTION INTO THE CANNULA DURING PREPARATION OF THE PROCEDURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794574 ↗
• MalfunctionApr 2, 2026Obstruction of Flow; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THERE WAS A DIFFICULTY WITH SUCTION THROUGH THE SIDE SUCTION TUBE, MAKING ASPIRATION DIFFICULT, AND THE CUFF SHOWED SIGNS OF AIR LEAKAGE. IT WAS ALSO MENTIONED THAT WHEN THE CUFF WAS DEFLATED, IT WAS OBSERVED THAT THE PATIENT COUGHED UP A LARGE AMOUNT OF SPUTUM. IN ADDITION TO NEGATIVE PRESSURE SUCTION, CLINICAL ATTEMPTS HAVE INCLUDED USING A SYRINGE TO ASPIRATE SECRETIONS THROUGH THE SUBGLOTTIC REGION, BUT SUCTION WAS DIFFICULT. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24769610 ↗
• MalfunctionMar 30, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712693 ↗
• MalfunctionMar 18, 2026Obstruction of Flow; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THERE WAS A DIFFICULTY WITH SUCTION THROUGH THE SIDE SUCTION TUBE, MAKING ASPIRATION DIFFICULT, AND THE CUFF SHOWED SIGNS OF AIR LEAKAGE. IT WAS ALSO MENTIONED THAT WHEN THE CUFF WAS DEFLATED, IT WAS OBSERVED THAT THE PATIENT COUGHED UP A LARGE AMOUNT OF SPUTUM. IN ADDITION TO NEGATIVE PRESSURE SUCTION, CLINICAL ATTEMPTS HAVE INCLUDED USING A SYRINGE TO ASPIRATE SECRETIONS THROUGH THE SUBGLOTTIC REGION, BUT SUCTION WAS DIFFICULT. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24634379 ↗
• MalfunctionFeb 2, 2026Mechanical Problem

  IT WAS REPORTED THAT INTRA-OPERATIVELY, WHILE USING THE TRACHEOSTOMY TUBE, IT WAS UNABLE TO EXTRACT SPUTUM USING THE SUBGLOTTIC SUCTION CATHETER IN COMBINATION WITH NEGATIVE PRESSURE SUCTION FROM ABOVE THE CUFF. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24242459 ↗
• MalfunctionFeb 2, 2026Mechanical Problem

  IT WAS REPORTED THAT INTRA-OPERATIVELY; WHILE USING THE TRACHEOSTOMY TUBE, IT WAS UNABLE TO EXTRACT SPUTUM USING THE SUBGLOTTIC SUCTION CATHETER IN COMBINATION WITH NEGATIVE PRESSURE SUCTION FROM ABOVE THE CUFF. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24242447 ↗
• MalfunctionJan 3, 2025Gas/Air Leak; Human-Device Interface Problem; Gas/Air Leak; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TWO TRACHEOSTOMY TUBES DID NOT HOLD PRESSURE AND HAD BEEN CONSISTENTLY LEAKING. THE PRESSURE WAS SET AND MAINTAINED AT A PRESSURE OF 20 TO 30 CMH2O, BUT THE PRESSURE WAS DOWN TO BETWEEN 10 AND 20 WITHIN 24 HOURS, SOMETIMES LESS THAN 8 HOURS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Discomfort; Pain

  MAUDE report 21064601 ↗
• MalfunctionDec 9, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, LEAKAGE WAS OBSERVED WHEN THE TRACHEOSTOMY'S BALLOON WAS INFLATED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878486 ↗
• MalfunctionJul 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE PATIENT HAD FIRST TIME TRACHEOTOMY PROCEDURE AND THE TRACHEOSTOMY TUBE DID NOT SEAL PROPERLY DUE TO A LEAKAGE. THE TRACH WAS REPLACED. IT WAS ALSO STATED THAT THE PHYSICIAN TESTED ANOTHER TRACH BUT COULD NOT USE AS IT WAS ALSO LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684608 ↗
• MalfunctionJul 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE PATIENT HAD A FIRST TIME TRACHEOTOMY PROCEDURE, AND THE TRACHEOSTOMY TUBE DID NOT SEAL PROPERLY DUE TO A LEAKAGE. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19670986 ↗
• MalfunctionJul 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE PATIENT HAD A FIRST TIME TRACHEOTOMY PROCEDURE, AND THE TRACHEOSTOMY TUBE DID NOT SEAL PROPERLY DUE TO A LEAKAGE. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19670712 ↗
• MalfunctionJul 3, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF LEAKED DURING ONE TO TWO DAYS AFTER INSERTION. THE TUBE WAS REPLACED

  Patient problems: Unintended Extubation

  MAUDE report 19669890 ↗
• MalfunctionJul 3, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF LEAKED DURING ONE TO TWO DAYS AFTER INSERTION. THE TUBE WAS REPLACED

  Patient problems: Unintended Extubation

  MAUDE report 19669335 ↗
• MalfunctionJul 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE PATIENT HAD A FIRST TIME TRACHEOTOMY PROCEDURE AND THE TRACHEOSTOMY TUBE DID NOT SEAL PROPERLY DUE TO A LEAKAGE. THE TRACH WAS REPLACED. IT WAS ALSO STATED THAT THE PHYSICIAN TESTED ANOTHER TRACH BUT COULD NOT USE AS IT WAS ALSO LEAKING.

  Patient problems: Unintended Extubation

  MAUDE report 19666146 ↗
• MalfunctionJun 21, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF LEAKED ONE TO TWO DAYS AFTER INSERTION. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19585937 ↗
• MalfunctionNov 30, 2023Missing Information; Missing Information

  ACCORDING TO THE REPORTER, THE LABELING OF THE TRACHEOSTOMY TUBE DID NOT MATCH THE DEVICE INSIDE THE PACKAGING. THE NURSE ASKED FOR THE SIZE 6 TUBE, AND AFTER THE TUBE WAS INSERTED INTO THE PATIENT, IT WAS DISCOVERED THAT THE TUBE WAS SIZE 4. IT WAS ALSO REPORTEDTHAT THE EXTERNAL BOX HAD A DIFFERENT LOOK COMPARED TO THE PACKAGING INSIDE. MANAGE WITH SMALLER SIZE OF THE TUBE AND THE REPLACED WITH CORRECT SIZE.

  Patient problems: Unintended Extubation

  MAUDE report 18243514 ↗
• InjuryOct 17, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE HAD A LEAK, AND THE PATIENT'S BREATHING WAS NOT STABLE AFTER TWO DAYS OF USED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 17954184 ↗