Shiley 6.0PLCF (UDI 10884521103597)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521103597), received between Jul 21, 2020 and Nov 8, 2024 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20639901 ↗
• MalfunctionJul 8, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-TEST, BOTH OF THE TRACHEOSTOMY TUBES' CUFFS HAD A LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19692538 ↗
• MalfunctionJun 3, 2024Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S INFLATION LINE WAS FOUND TO BE CUT, WHICH TRIGGERED A LEAK ALARM FROM THE VENTILATOR. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19454520 ↗
• MalfunctionFeb 9, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S PILOT BALLOON HAD A CRACKED ON THE CONNECTION REGION DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18679867 ↗
• MalfunctionJan 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD INFLATION OR DEFLATION ISSUE AFTER THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504356 ↗
• MalfunctionJan 10, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INFLATION LINE DISCONNECTED DURING USE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 18486382 ↗
• MalfunctionJan 10, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, IT WAS CONFIRMED THAT THE TRACHEOSTOMY TUBE'S CUFF DEFLATED DURING REPLACEMENT ON THE 5TH DAY. AT THAT TIME, IT WAS THOUGHT THAT IT WAS FORGOTTEN TO INFLATE THE CUFF, SO AIR WAS INJECTED INTO THE CUFF. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18486369 ↗
• MalfunctionNov 22, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBES WAS BROKEN FROM THE PROXIMAL SITE OF THE INFLATION LINE DURING USE AT HOME. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18193964 ↗
• MalfunctionOct 18, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF PRESSURE WAS BEING MANAGED AT 20CMH2O, BUT IT WAS FOUND TO HAVE TURNED INTO 10CMH2O. AN ATTEMPT WAS MADE TO USE ANOTHER CUFF PRESSURE MONITOR BUT THE SAME CONDITION OCCURRED. THE TUBE WAS REPLACED WITH A SAME SIZE AND RESOLVED THE ISSUE.

  Patient problems: Unintended Extubation

  MAUDE report 17958666 ↗
• MalfunctionJul 3, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF PRESSURE GAUGE DID NOT IMMEDIATELY INCREASE THE CUFF PRESSURE, AND IT WAS BELIEVED THAT THE CAUSE WAS THE TRACHEOSTOMY TUBE, SO THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17248405 ↗
• MalfunctionMar 9, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF INFLATION OR DEFLATION ISSUE AND A PILOT BALLOON ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16514213 ↗
• MalfunctionJan 12, 2023Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE WAS PROPERLY INFLATED/DEFLATED DURING THE PRE-USAGE INSPECTION. HOWEVER, SEVERAL DAYS LATER, THE PATIENT'S PARENTS NOTICED THAT THE AIR WAS COMING OUT. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 16150649 ↗
• MalfunctionSep 19, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE CANNULA KEPT "COMING OFF" A FEW DAYS AFTER PLACEMENT. THE EVENT OCCURRED ALMOST DAILY. HOWEVER, IT VARIES HOW BADLY THE CUFF GOES OFF. SOMETIMES IT IS BY 0.1ML, OTHER TIMES IT IS BY 0.5ML. THEY TRY TO CHECK THE CUFF ITSELF 3 TIMES DAILY. RECANNULATION WAS NOT REQUIRED AND THERE WAS NO PATIENT HARM.

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

  MAUDE report 15451574 ↗
• MalfunctionSep 17, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF WAS NOT TESTED PRIOR TO USE. THE CUFF OF THE CANNULA KEPT "COMING OFF" A FEW DAYS AFTER PLACEMENT. THE CANNULA WAS CHANGED. XYLOGEN WAS USED TO LUBRICATE THE CUFF. WHEN THE CUFF WAS TESTED AFTERWARDS, IT WAS CONFIRMED THAT THE CUFF GOES FROM 3.5ML TO 2.4ML, SO THERE WAS A LOSS WITHOUT KNOWING WHY. THE EVENT OCCURRED ALMOST DAILY. HOWEVER, IT VARIES HOW BADLY THE CUFF GOES OFF. SOMETIMES IT IS BY 0.1ML, OTHER TIMES IT IS BY 0.5ML. THEY TRY TO CHECK THE CUFF ITSELF 3 TIMES DAILY.

  Patient problems: Unintended Extubation

  MAUDE report 15443092 ↗
• InjuryFeb 16, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DUE TO CUFF AND PILOT BALLOON ISSUE, THE PATIENT REQUIRED MORE SUCTIONING THAN ON PREVIOUS TUBES (EVERY 10 MIN). THIS CAUSED ASPIRATION PNEUMONIA.

  Patient problems: Pneumonia

  MAUDE report 13543429 ↗
• MalfunctionApr 29, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CONNECTION CABLE TO THE CUFF CAME OFF AFTER 6 DAYS OF BEING IN PLACED. THE PATIENT WAS RECANNULATED BUT NO PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 11744618 ↗
• InjuryJul 21, 2020Gas/Air Leak; Separation Problem; Gas/Air Leak; Separation Problem

  ACCORDING TO THE REPORTER, THE PATIENT IS SEVERELY BRAIN DAMAGED AFTER A NEONATAL ASPHYXIA. A REPLACEMENT OF A TRACHEAL CANNULA WAS IN NEED BECAUSE OF THE REPORTED LOW CUFF PRESSURE. THE MOTHER OF THE PATIENT FEELS THAT IT LEAKS WATER FROM THE TRACHEOSTOMY HOLE WHEN SHE LETS HIM MOISTEN THE MOUTH. THE PATIENT MEASURED WITH MINOR IRRITATION OF THE RESPIRATORY TRACT SUCH AS MORE MUCUS (UNSTAINED), BUT HAD NO RESPIRATORY DISTRESS, AND NO DESATURATIONS DESCRIBED. WHEN THE OLD TRACHEAL CANNULA WAS REPLACED, IT WAS FOUND THAT THE CUFF WAS NO LONGER ATTACHED TO THE CANNULA BUT HAD RELEASED IN ITS ENTIRETY. THERE WAS ALSO A SMALL LESION ON THE PATIENTS RIGHT SIDE OF THE TRACHEAL CANNULA ABOUT 1 CM FROM THE TIP, NO MISSING PIECE OF THE TRACHEAL CANNULA NOR THE CUFF. THE DETACHED CUFF, THAT WAS LYING ON CARINA AND PARTIALLY OBSTRUCTING BOTH MAIN BRONCHI, WAS ABLE TO REMOVED THRU THE NEW TRACHEAL CANNULA.

  Patient problems: Airway Obstruction; Extubate; Irritation; Respiratory Tract Infection

  MAUDE report 10302473 ↗