Shiley 4.5PCF (UDI 10884521103542)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10884521103542), received between Dec 22, 2020 and Jul 23, 2025 — classified as 5 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (20 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE AIR FROM THE CUFF OF THE ENDOTRACHEAL TUBE LEAKED DURING PATIENT USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22580121 ↗
• MalfunctionMay 21, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT, AFTER A MONTH OF INTUBATION, VENTILATOR ALARM SOUNDED, THE TRACH TUBE'S CUFF WAS NOT INCREASING PRESSURE DESPITE AIR WAS INSERTED. MOISTURE WAS ALSO OBSERVED IN THE INFLATION LINE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22063323 ↗
• InjuryNov 20, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT'S SPO2 DECREASED TO 85%, AND UPON CONFIRMATION, THE CUFF PRESSURE OF THE TRACHEOSTOMY TUBE DID NOT INCREASE AND THE PILOT BALLOON HAD A DAMAGE. REPLACEMENT OF THE TUBE WAS DONE, AND THE PATIENT'S CONDITION WAS IMPROVED.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 20736952 ↗
• InjuryOct 2, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER 4 WEEKS OF USE, THE TRACHEOSTOMY TUBE'S PROXIMAL SIDE OF THE INFLATION LINE WAS DISCONNECTED FROM THE VENTILATOR AND NOTICE THAT THE VENTILATION VOLUME CANNOT BE MAINTAINED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Hypoventilation; Insufficient Information; Unintended Extubation

  MAUDE report 20355125 ↗
• MalfunctionOct 2, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE INFLATION LINE OF THE TRACHEOSTOMY TUBE HAD A TEAR, AND THE CUFF WAS DEFLATED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 20350408 ↗
• MalfunctionSep 18, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S INFLATION LINE WAS FOUND DAMAGED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20246991 ↗
• MalfunctionAug 9, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE INFLATION LINE OF THE TRACHEOSTOMY TUBE HAD A TEAR, AND THE CUFF WAS DEFLATED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19946631 ↗
• MalfunctionAug 8, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE INFLATION LINE OF THE TRACHEOSTOMY TUBE HAD A TEAR, AND THE CUFF WAS DEFLATED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19944094 ↗
• MalfunctionJul 22, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE TRACHEOSTOMY TUBE HAD AN AIR LEAK. WHEN THE CUFF PRESSURE WAS CHECKED WHEN PERFORMING THE CUFF ASSIST, IT WAS ONLY AT 10 MMHG, RESET WAS DONE TO 30 MMHG. AFTER ONE HOUR, THE CUFF PRESSURE WAS CHECKED, AND IT WENT TO 10 MMHG AGAIN. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19798762 ↗
• MalfunctionJul 5, 2024Crack; Crack

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAD A CRACK AT THE PROXIMAL OF THE INFLATION LINE AFTER THREE DAYS OF BEING USE. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19684649 ↗
• MalfunctionMay 22, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA'S PILOT LINE HAD A LEAK DURING USE. THE TRACHEOSTOMY WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19375661 ↗
• MalfunctionMay 21, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA'S PILOT LINE HAD A LEAK DURING USE. THE TRACHEOSTOMY WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19367911 ↗
• MalfunctionMay 21, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA'S PILOT LINE HAD A LEAK DURING USE. THE TRACHEOSTOMY WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19367074 ↗
• MalfunctionMay 7, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT HAD TWO PRODUCT REPLACEMENT FOR ONE DAY AT HOME. THE TRACHEOSTOMY TUBE'S CUFF HAD AIR AND WATER MIXED INSIDE, AND WHEN THE AIR WAS INJECTED AFTER REMOVING THE WATER, THE AIR LEAKED AND THE CUFFS DEFLATED.

  Patient problems: Unintended Extubation

  MAUDE report 19260701 ↗
• MalfunctionApr 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD HOLE AFTER FOUR WEEKS OF NORMAL USE EVEN ON CLOSER INSPECTION BECAUSE IT DID NOT HARDEN WHEN AIR WAS INSERTED. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19168818 ↗
• InjuryApr 19, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF DEFLATED DURING USE THAT RESULTED TO THE INSPIRATORY PRESSURE TO DECREASED. THE PATIENT'S PULMONARY ALVEOLUS COLLAPSED. THE TUBE WAS REPLACED.

  Patient problems: Hypoventilation; Respiratory Insufficiency; Unintended Extubation

  MAUDE report 19148971 ↗
• MalfunctionApr 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, A TEAR WAS DISCOVERED AT THE BASE OF THE TRACHEOSTOMY TUBE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125228 ↗
• MalfunctionMar 28, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS DAMAGE TO THE TRACHEOSTOMY TUBE'S INFLATION LINE AND TUBE CONNECTION REGION DURING PATIENT USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18990386 ↗
• MalfunctionFeb 20, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AIR WAS NOT POSSIBLE TO BE INJECTED INTO THE CUFF IMMEDIATELY AFTER THE REPLACEMENT OF THE TRACHEOSTOMY TUBE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18744267 ↗
• MalfunctionDec 27, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE WAS INFLATED, BUT AIR LEAKED GRADUALLY, AND THE PILOT BALLOON DID NOT I NFLATE EVEN WHEN DEAERATED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 18407347 ↗
• MalfunctionDec 22, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S PILOT LINE WAS DISCOVERED LEAKING AIR WHEN REMOVED FOR REPLACEMENT AFTER TWO WEEKS OF PATIENT USED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380997 ↗
• MalfunctionNov 13, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT'S MOTHER REMOVED AS SCHEDULED REPLACEMENT OF THE TRACHEOSTOMY TUBE AFTER TWO WEEKS OF PLACEMENT. BECAUSE THE QUANTITY WAS CONTROLLED, SO A LARGE QUANTITY OF AIR WAS PUT IN WHILE USING IT. IT WAS THEN REPORTED TO THE FACILITY WHEREIN TESTED BY PLACING IN WATER AND WHEN AIR AS INJECTED AIR LEAKAGE WAS CONFIRMED.

  Patient problems: Unintended Extubation

  MAUDE report 18124805 ↗
• MalfunctionOct 10, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INFLATION LINE WAS FOUND DISCONNECTED FROM THE TUBE DURING USE. THE PRODUCT WAS REPLACED WITH A NEW ONE.

  Patient problems: Unintended Extubation

  MAUDE report 17906221 ↗
• MalfunctionOct 7, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF DID NOT INFLATE WHEN AIR WAS INSERTED AFTER TUBE REPLACEMENT. UPON CONFIRMATION, AIR LEAKED AT THE PROXIMAL SIDE OF THE INFLATION LINE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17892546 ↗
• MalfunctionOct 7, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF DID NOT INFLATE WHEN AIR WAS INSERTED AFTER TUBE REPLACEMENT. UPON CONFIRMATION, AIR LEAKED AT THE PROXIMAL SIDE OF THE INFLATION LINE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17892545 ↗