Shiley 5.5PLCF (UDI 20884521779928)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 20884521779928), received between Oct 20, 2021 and Nov 26, 2025 — classified as 3 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (29 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE INSERTION AND REMOVAL OF THE TRACHEOSTOMY'S OBTURATOR FELT A RESISTANCE, AND IT WAS DIFFICULT TO INSERT AND REMOVE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662816 ↗
• MalfunctionMar 19, 2025Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE HAD A HOLE AND AIR COULD NOT BE ENTERED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642973 ↗
• MalfunctionFeb 4, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT A TRACH TUBE WITH A 5.5 CUFFED EXPERIENCED ISSUES AT A HOME SETTING. AFTER 3 DAYS OF USE, THE CUFF DEFLATED, AND THE TRACH TUBE WOULD NOT STAY IN PLACE. THE TUBE WAS REPLACED. THE CUFF WAS TESTED AFTER BEING REMOVED, AND NO BUBBLES WAS SEEN, BUT THE CUFF SEEMED TO DEFLATE SLOWLY AND DID NOT SEEM TO BE VERY FIRM.

  Patient problems: Unintended Extubation

  MAUDE report 21309524 ↗
• MalfunctionNov 27, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE TWO TRACHEOSTOMY TUBE LEAK AIR DURING PLACEMENT. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 20802821 ↗
• MalfunctionNov 26, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE TWO TRACHEOSTOMY TUBE LEAK AIR DURING PLACEMENT. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 20778851 ↗
• MalfunctionOct 14, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS AIR LEAKAGE FROM THE TRACHEOSTOMY TUBE'S CUFF. THE TRACH WAS REPLACED.

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

  MAUDE report 20446290 ↗
• MalfunctionAug 28, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF THE TRACHEOSTOMY TUBE WAS UNABLE TO BE INFLATED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085158 ↗
• MalfunctionAug 5, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS AN AIR LEAK FROM THE PROXIMAL PART (ROOT PART) OF THE CUFF OF THE TRACHEOSTOMY TUBE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19906251 ↗
• MalfunctionJun 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF DID NOT INFLATE DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538464 ↗
• MalfunctionMar 11, 2024Use of Device Problem; Defective Component; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn; Use of Device Problem; Defective Component; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, A LOSS OF SEAL ON THE CUFF WAS NOTICED. TRIED TO BLOCK THE INFLATION LINE WITH A KNOT, AND THERE WERE NO DEFLATION PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 18880512 ↗
• MalfunctionJan 30, 2024Crack; Use of Device Problem; Crack; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WERE AIR LEAK AND CRACKS AT THE PROXIMAL SIDE OF THE TRACHEOSTOMY TUBE'S PILOT LINE DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18610744 ↗
• MalfunctionDec 4, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, A CRACK FORMED AT THE PROXIMAL BASE OF THE TRACHEOSTOMY TUBE'S PILOT LINE AND HAD AN AIR LEAK DURING THE PROCEDURE. THE TUBE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257738 ↗
• MalfunctionNov 13, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE WAS SELF-INFLATING AFTER THE CUFF WAS DEFLATED AND THE SYRINGE WAS REMOVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18127897 ↗
• MalfunctionNov 13, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE WAS SELF-INFLATING AFTER THE CUFF WAS DEFLATED AND THE SYRINGE WAS REMOVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18127894 ↗
• MalfunctionOct 27, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF DID NOT INFLATE DUE TO A DAMAGED INFLATION LINE DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18022495 ↗
• MalfunctionJul 20, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY'S BALLOON VALVE AND CUFF DID NOT STAY INFLATED DURING USE AND LASTED TWO WEEKS. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 17367533 ↗
• MalfunctionMay 5, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PILOT VALVE OF THE TRACH WAS DISCONNECTED FROM THE PILOT LINE. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 16880299 ↗
• MalfunctionJan 12, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER 19 DAYS FROM THE PLACEMENT OF THE TRACHEOSTOMY TUBE A VERY DISABLED PATIENT WITH CHRONIC RESPIRATORY FAILURE, THE CAREGIVER DURING DAILY NURSING ACTIVITIES AND POSTURAL VARIATION OF THE PATIENT. FOUND THE DETACHMENT OF THE CUFF INFLATION TUBE, AT THE POINT WHERE IT CONNECTS TO THE CANNULA FLANGE. THE PATENT NORMALLY KEEPS THE CANNULA DEFLECTED. THE CUFF NEEDED TO BE INFLATED DURING THE RESPIRATORY FAILURE EXACERBATION, MECHANICAL VENTILATION WOULD NOT HAVE BEEN SUFFICIENTLY EFFICIENT. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 16150996 ↗
• MalfunctionJan 12, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS PLACED ON THE PATIENT, DURING DAILY ACTIVITIES OF NURSING AND POSTURAL VARIATION OF THE PATIENT, IT WAS FOUND THAT THE CUFF INFLATION TUBE WAS DETACHED FROM THE CANNULA FLANGE.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 16150850 ↗
• MalfunctionJan 12, 2023Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, SIMILAR PROBLEMS WERE DETECTED ON THREE IDENTICAL TUBES FROM THE SAME LOT. CONTINUOUS ALARMS COMING FROM THE MECHANICAL VENTILATOR, REFERRING TO HIGH CIRCUIT LOSSES. UPON SUBSEQUENT INSPECTION BY THE ANESTHESIOLOGIST, A LEAK FROM THE CUFF WAS DETECTED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16150702 ↗
• MalfunctionJan 12, 2023Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, SIMILAR PROBLEMS WERE DETECTED ON THREE IDENTICAL TUBES FROM THE SAME LOT. CONTINUOUS ALARMS COMING FROM THE MECHANICAL VENTILATOR, REFERRING TO HIGH CIRCUIT LOSSES. UPON SUBSEQUENT INSPECTION BY THE ANESTHESIOLOGIST, A LEAK FROM THE CUFF WAS DETECTED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16150657 ↗
• InjuryJan 12, 2023Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PATIENT HAD CHRONIC RESPIRATORY FAILURE, CARRIER OF TRACHEOSTOMY AND MECHANICALLY VENTILATED. NINE DAYS AFTER PLACEMENT OF THE TUBE, MECHANICAL VENTILATOR HAD A CONTINUOUS ALARMS BECAUSE OF HIGH CIRCUIT LEAKS WAS DETECTED WITH INABILITY TO DELIVER THE SET PRESSURE SUPPORT AND CONSEQUENT HYPOVENTILATION. AT A SUBSEQUENT INSPECTION WAS PERFORMED, A LEAK WAS IDENTIFIED FROM THE INFLATION TUBE. FAILURE OF THE TUBE CUFF INFLATION WAS FOUND RESULTING IN URGENT REPLACEMENT OF THE TUBE.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 16150579 ↗
• MalfunctionJan 12, 2023Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn; Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE VENTILATOR CONTINUED TO ALARM, AND IT WAS DISCOVERED THAT THE DEVICE'S CUFF WAS BROKEN AND DID NOT INFLATE DURING REPLACEMENT.

  Patient problems: Unintended Extubation

  MAUDE report 16150392 ↗
• MalfunctionJan 12, 2023Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, SIMILAR PROBLEMS WERE DETECTED ON THREE IDENTICAL TUBES FROM THE SAME LOT. CONTINUOUS ALARMS COMING FROM THE MECHANICAL VENTILATOR, REFERRING TO HIGH CIRCUIT LOSSES. UPON SUBSEQUENT INSPECTION BY THE ANESTHESIOLOGIST, A LEAK FROM THE CUFF WAS DETECTED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16146091 ↗
• InjuryJan 12, 2023Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PATIENT HAD CHRONIC RESPIRATORY FAILURE, CARRIER OF TRACHEOSTOMY AND MECHANICALLY VENTILATED. TWENTY-FOUR DAYS AFTER PLACEMENT OF THE TUBE, MECHANICAL VENTILATOR HAD A CONTINUOUS ALARMS BECAUSE OF HIGH CIRCUIT LEAKS WAS DETECTED WITH INABILITY TO DELIVER THE SET PRESSURE SUPPORT AND CONSEQUENT HYPOVENTILATION. AT A SUBSEQUENT INSPECTION WAS PERFORMED, A LEAK WAS IDENTIFIED FROM THE INFLATION TUBE. FAILURE OF THE TUBE CUFF INFLATION WAS FOUND RESULTING IN URGENT REPLACEMENT OF THE TUBE.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 16143930 ↗