Shiley 6.5PLCF (UDI 20884521779942)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 20884521779942), received between Mar 2, 2022 and Mar 9, 2026 — classified as 7 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (27 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.

• MalfunctionMar 9, 2026Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAKAGE FROM THE CUFF AFTER TWO DAYS OF USE BY THE PATIENT, AND THE TUBE WAS REMOVED OR CAME OUT FROM THE PATIENT. FROM THE INFLATION LINE, AIR WAS TRIED TO INSERT, BUT THE AIR DID NOT GO IN. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24551496 ↗
• MalfunctionDec 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE TRACH TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794695 ↗
• MalfunctionAug 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, A HOLE WAS FOUND FROM THE BASE OF THE TRACH TUBE'S INFLATION LINE, AS ILLUSTRATED IN THE ATTACHMENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22844258 ↗
• MalfunctionJul 2, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT THE INSERTION AND REMOVAL OF THE OBTURATOR WERE HARD PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391561 ↗
• MalfunctionMar 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING USE, THE TRACHEOSTOMY TUBE WAS DISLODGED FROM A PATIENT AT HOME. IT WAS UNCERTAIN IF IT WAS OUTWARD APPEARANCE OR DAMAGE TO THE CUFF. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21575083 ↗
• MalfunctionJan 10, 2025Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF DID NOT INFLATE EVEN WHEN AIR WAS ADDED. THE TUBE WAS REPLACED.

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

  MAUDE report 21132269 ↗
• MalfunctionOct 30, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S BALLOON BURST AFTER 48 HOURS OF CHANGED. THERE WAS NO PATIENT HARM.

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

  MAUDE report 20569154 ↗
• MalfunctionOct 18, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD PROBLEM WITH INFLATING DURING THE INFLATION TEST PRIOR TO THE PLACEMENT OF THE CANNULA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482315 ↗
• MalfunctionOct 18, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD PROBLEM WITH INFLATING DURING THE INFLATION TEST PRIOR TO THE PLACEMENT OF THE CANNULA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482269 ↗
• InjurySep 3, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S PILOT VALVE WAS LEAKING THROUGH THE VENTILATOR CIRCUIT AND WAS REPLACED THREE TIMES WITHIN TWO WEEKS. THE PATIENT EXPERIENCED CHOKING, SALIVATION, AND SATURATION DROPPED.

  Patient problems: Choking; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 20127920 ↗
• InjurySep 3, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S PILOT VALVE WAS LEAKING THROUGH THE VENTILATOR CIRCUIT AND WAS REPLACED THREE TIMES WITHIN TWO WEEKS. THE PATIENT EXPERIENCED CHOKING, SALIVATION, AND SATURATION DROPPED.

  Patient problems: Choking; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 20127858 ↗
• InjurySep 3, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S PILOT VALVE WAS LEAKING THROUGH THE VENTILATOR CIRCUIT AND WAS REPLACED THREE TIMES WITHIN TWO WEEKS. THE PATIENT EXPERIENCED CHOKING, SALIVATION, AND SATURATION DROPPED.

  Patient problems: Choking; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 20127849 ↗
• MalfunctionMar 15, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INFLATION LINE BROKE INTO PIECES AFTER IT WAS PULLED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18917783 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CONNECTION PART WITH THE TUBE OF THE INFLATION LINE WAS WOBBLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852545 ↗
• InjuryJan 12, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE FIRST TRACHEOSTOMY TUBE HAD AN AIR LEAK. AN EMERGENCY RESPONSE WAS PROVIDED BY INJECTING AIR. EVEN WHEN AIR WAS INJECTED, THE CUFF PRESSURE DID NOT GO UP, SO THE PATIENT WAS TAKEN FOR AN EMERGENCY MEDICAL CONSULTATION AND TRACHEOSTOMY TUBE REPLACEMENT WAS PERFORMED. ON THE SECOND DEVICE, IT WAS STATED THAT THERE WERE SEVERAL EMERGENCY VISITS IN THE FACILITY DUE TO CUFF LEAKS, AND THE PREVIOUS DEFECTIVE PRODUCT WAS DAMAGED ON THE INFLATOR LINE PART. ALSO, THERE WERE TIMES WHEN THE PATIENT PLAYED WITH THE LINES, SO NOW THE INFLATOR LINES ARE TAPED AND FIXED TOGETHER. A CUFF LEAK WAS DISCOVERED WHEN A SOUND WAS HEARD LEAKING THROUGH THE VOCAL CORDS. RESPIRATORY MANAGEMENT WAS PERFORMED.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 18508826 ↗
• InjuryJan 12, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE FIRST TRACHEOSTOMY TUBE HAD AN AIR LEAK. AN EMERGENCY RESPONSE WAS PROVIDED BY INJECTING AIR. EVEN WHEN AIR WAS INJECTED, THE CUFF PRESSURE DID NOT GO UP, SO THE PATIENT WAS TAKEN FOR AN EMERGENCY MEDICAL CONSULTATION AND TRACHEOSTOMY TUBE REPLACEMENT WAS PERFORMED. ON THE SECOND DEVICE, IT WAS STATED THAT THERE WERE SEVERAL EMERGENCY VISITS IN THE FACILITY DUE TO CUFF LEAKS, AND THE PREVIOUS DEFECTIVE PRODUCT WAS DAMAGED ON THE INFLATOR LINE PART. ALSO, THERE WERE TIMES WHEN THE PATIENT PLAYED WITH THE LINES, SO NOW THE INFLATOR LINES ARE TAPED AND FIXED TOGETHER. A CUFF LEAK WAS DISCOVERED WHEN A SOUND WAS HEARD LEAKING THROUGH THE VOCAL CORDS. RESPIRATORY MANAGEMENT WAS PERFORMED.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 18508820 ↗
• MalfunctionJan 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DEFLATED EVEN AFTER AIR WAS INSERTED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18506573 ↗
• MalfunctionJan 9, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF "BURST" SPONTANEOUSLY THREE TO FOUR DAYS DURING USE. AFTER THE CUFF "BURST," MORE AND MORE SECRETIONS BEGAN TO APPEAR, WHICH WENT DOWN THE PATIENT'S THROAT INSTEAD OF THROUGH THE TUBE. THE PATIENT WAS VERY TIRED AND COULD NOT SLEEP AT NIGHT BECAUSE SECRETIONS KEPT APPEARING. THE PATIENT'S TUBE WAS REPLACED, AND HAD BEEN USING CUFFED TUBES FOR SOME TIME FROM A DIFFERENT MANUFACTURER.

  Patient problems: Sleep Dysfunction; Unintended Extubation

  MAUDE report 18472984 ↗
• MalfunctionDec 21, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF WAS LEAKING AIR EVEN RE-INJECTING AIR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373788 ↗
• MalfunctionDec 8, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK AFTER SEVERAL DAYS OF PATIENT USAGE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18296939 ↗
• MalfunctionNov 16, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF WAS INFLATED BUT THE CUFF PRESSURE CANNOT BE MAINTAINED DURING USE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 18150581 ↗
• MalfunctionNov 13, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE HAD A LEAK AND DID NOT INFLATE DURING TESTING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124878 ↗
• MalfunctionOct 18, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACH'S CUFF WAS FOUND NO PRESSURE AFTER 30 DAYS OF PATIENT USE, SAME SITUATION EVEN WHEN AIR WAS REINSERTED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17961792 ↗
• MalfunctionOct 4, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACH TUBE'S CUFF WAS NOT INFLATING AFTER A MONTH OF PATIENT USAGE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17873038 ↗
• MalfunctionSep 21, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS A CRACK FOUND IN THE TRACHEOSTOMY TUBE'S INFLATION LINE THAT CAUSED THE DEFLATION OF THE CUFF AFTER A FEW DAYS OF PATIENT USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788914 ↗