Shiley 4.0PCF (UDI 20884521779706)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 20884521779706), received between May 31, 2022 and Jun 2, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Use of Device Problem

  IT WAS REPORTED THAT WHEN THE TRACHEOSTOMY TUBE'S CUFF WAS INFLATED WHILE BEING TESTED, THE CUFF BURST. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25367456 ↗
• MalfunctionSep 16, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE AIR IN THE CUFF OF THE TRACHEOSTOMY TUBE WAS MANAGED AT 25 MMHG, BUT ONE WEEK AFTER USE, THE AIR NATURALLY REMOVED OR DEFLATED TO ABOUT 20 MMHG. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 23066528 ↗
• MalfunctionAug 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF WAS DAMAGED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22924857 ↗
• MalfunctionApr 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING CUFF TESTING, WHEN 2CC OF AIR WAS INSERTED USING A SYRINGE, THE CUFF OF THE TRACHEOSTOMY TUBE "RUPTURED" AS SHOWN IN THE ATTACHED PHOTO. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887120 ↗
• MalfunctionSep 19, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, WHILE IN USE AT THE PATIENT'S HOME, THE CUFF DEFLATED AND WAS REPLACED. A WATER IMMERSION TEST REVEALED AN AIR LEAK AT THE CONNECTION BETWEEN THE INFLATION LINE AND THE TUBE. THE INCIDENT CAUSED NO HARM TO THE PATIENT'S HEALTH, AND ALL EVENTS OCCURRED SIMILARLY.

  Patient problems: Unintended Extubation

  MAUDE report 20256305 ↗
• MalfunctionJul 24, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE CUFF OF THE TRACHEOSTOMY TUBE HAD INFLATION AND DEFLATION ISSUES. THERE WAS NO PATI ENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818309 ↗
• MalfunctionJun 7, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE AIR COULD NOT BE REMOVED SMOOTHLY FROM THE TRACHEOSTOMY TUBE'S CUFF DURING THE PRE-USAGE INSPECTION. IT COULD BE DEFLATED OVER TIME, BUT IT COULD NOT BE DEFLATED IN NORMAL TIME. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486105 ↗
• MalfunctionMay 7, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF PRESSURE WAS FOUND DECREASE DURING A SCHEDULED REPLACEMENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264581 ↗
• MalfunctionApr 22, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK AND UNABLE TO INFLATE FULLY DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152330 ↗
• MalfunctionOct 24, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER THE TUBE WAS PLACED, THE PRESSURE IN THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT INCREASE, SO THE CUFF WAS DEFLATED AND INFLATED ONCE, BUT THE PRESSURE STILL DID NOT INCREASE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 17996196 ↗
• MalfunctionOct 20, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD A LEAK AFTER TWO WEEKS OF PATIENT USE. THIS WAS DUE TO PILOT BALLOON AND INFLATION LINE MALFUNCTIONED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17976928 ↗
• MalfunctionSep 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAD A LEAK AFTER 10 DAYS TO 2 WEEKS OF BEING USED. THE LEAK PORTION WAS CHECKED BUT IT WAS NOT KNOWN. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 17844847 ↗
• MalfunctionSep 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAD A LEAK DURING USE. IT WAS UNKNOWN WHERE THE LEAK WAS COMING FROM AND THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17786252 ↗
• MalfunctionSep 6, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE INFLATION LINE CAME OFF FROM THE TRACHEOSTOMY TUBE AND WAS ON TOP OF THE PATIENT'S BODY. IT WAS ALSO STATED THAT THE CUFF WAS DEFLATED. THE PILOT BALLOON WAS DENTED AND IMMEDIATELY INFLATED WHEN NEGATIVE PRESSURE WAS APPLIED. EVEN THOUGH THE PILOT BALLOON WAS INFLATED, BUT THE CUFF WAS NOT. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 17695207 ↗
• MalfunctionAug 25, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, A BREAKAGE WAS FOUND IN THE PILOT LINE OF THE TRACHEOSTOMY TUBE POST-OPERATIVELY. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 17628078 ↗
• MalfunctionAug 14, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF DID NOT MAINTAIN PRESSURE DURING THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547362 ↗
• MalfunctionAug 11, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT MAINTAIN PRESSURE DURING A PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17512521 ↗
• MalfunctionAug 11, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT MAINTAINED PRESSURE DURING A PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17512488 ↗
• MalfunctionMar 1, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CONNECTOR WAS BROKEN WHILE IN USE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 16464054 ↗
• MalfunctionFeb 14, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF WAS TESTED PRIOR TO USE, CUFF HAD A INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371545 ↗
• MalfunctionJul 1, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF DID NOT KEEP THE PRESSURE. THERE WAS NO OBVIOUS SIGN OF THE CUFF BEING TORN APART. THE CUFF WAS NOT TESTED PRIOR TO USE. RECANNULATION WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 14886040 ↗
• MalfunctionMay 31, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE WAS TESTED WITH A SYRINGE PRIOR TO USE BUT THE CUFF WOULD NOT INFLATE. THEY PLACED ANOTHER TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549341 ↗
• MalfunctionMay 31, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE WAS TESTED WITH A SYRINGE PRIOR TO USE BUT THE CUFF WOULD NOT INFLATE. THEY PLACED ANOTHER TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549251 ↗