Shiley 4.5PCF (UDI 20884521779713)Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 20884521779713), received between Jan 7, 2022 and Jun 17, 2026 — classified as 5 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (35 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Gas/Air Leak

  IT WAS REPORTED THAT AFTER TWENTY-FOUR DAYS OF PATIENT USAGE, THE TRACH TUBE'S CUFF HAD A LEAK, WHEN THE SYRINGE CONTINUED TO DRAW AIR INDEFINITELY DURING CUFF CHECK. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 25537796 ↗
• MalfunctionApr 30, 2026Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUFF AND INFLATION LINE OF THE TRACHEOSTOMY TUBE HAD A SLIT ON THE PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048313 ↗
• MalfunctionApr 21, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING CUFF CHECK OF THE TRACHEOSTOMY TUBE RESISTANCE WAS FELT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941701 ↗
• MalfunctionApr 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TRACH TUBE'S CUFF WAS NOT INFLATING CORRECTLY, A NEW TUBE WAS USED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24833033 ↗
• MalfunctionApr 7, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING INSPECTION, THE TRACH TUBE'S CUFF HAD A RAPID AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800199 ↗
• MalfunctionDec 5, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE AIR BEGAN TO LEAK FROM THE CUFF A FEW DAYS AFTER USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 23735080 ↗
• MalfunctionDec 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE AIR BEGAN TO LEAK FROM THE CUFF A FEW DAYS AFTER USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 23723340 ↗
• MalfunctionDec 2, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TRACH TUBE'S CUFF HAD A RAPID AIR LEAK AFTER THREE DAYS OF PATIENT USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 23693513 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE TRACHEOSTOMY TUBE'S PILOT BALLOON DID NOT INFLATE, NECESSITATING REPLACEMENT OF THE CANNULA.

  Patient problems: Unintended Extubation

  MAUDE report 23575719 ↗
• MalfunctionNov 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A DAMAGE TO THE TRACHEOSTOMY TUBE'S INFLATION LINE NEAR THE INCISION HOLE SITE DURING USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480218 ↗
• MalfunctionNov 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A DAMAGE TO THE TRACHEOSTOMY TUBE'S INFLATION LINE NEAR THE INCISION HOLE SITE DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 23451957 ↗
• InjuryAug 25, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER A FEW DAYS, THE CUFF WAS FOUND TO HAVE DEFLATED, WHICH NECESSITATED AN URGENT CANNULA CHANGE. THE PATIENT EXPERIENCED RESPIRATORY DISTRESS DURING THE PROCESS.

  Patient problems: Respiratory Insufficiency; Unintended Extubation; Voice alteration

  MAUDE report 22889100 ↗
• InjuryAug 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF INFLATES AND DEFLATES ON ITS OWN DURING USE. THE PATIENT EXPERIENCED RESPIRATORY DISTRESS AND REQUIRED AN URGENT CANNULA CHANGE.

  Patient problems: Respiratory Insufficiency; Unintended Extubation; Voice alteration

  MAUDE report 22889060 ↗
• MalfunctionJun 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE PATIENT¿S SCHEDULED TUBE REPLACEMENT, IT WAS CONFIRMED THAT THERE WAS A CRACK AT THE CONNECTION PART BETWEEN THE TUBE AND THE INFLATION LINE. WHEN ATTEMPTING TO DEFLATE THE CUFF, IT COULD NOT BE DEFLATED. THE INFLATION LINE WAS CUT, AND DEFLATION WAS PERFORMED. THERE WAS NO PATIENT HARM.

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

  MAUDE report 22365389 ↗
• MalfunctionApr 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF DID NOT INFLATE NEATLY DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882183 ↗
• MalfunctionMar 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, BOTH TRACHEOSTOMY TUBE'S CUFF HAD LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627436 ↗
• MalfunctionMar 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, BOTH TRACHEOSTOMY TUBE'S CUFF HAD LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627424 ↗
• MalfunctionMar 14, 2025Contamination /Decontamination Problem; Material Integrity Problem; Contamination /Decontamination Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, PRIOR USE, THERE WAS A MOLD-LIKE OBJECT IN THE TRACHEOSTOMY TUBE. REPLACED WITH ANOTHER TUBE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE 15MM CONNECTOR A PIECE OF FLASH WHICH PARTIALLY OCCLUDES THE INNER DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604792 ↗
• MalfunctionFeb 11, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 4.5MM TRACHEOTOMY'S CUFF LEAKED AIR. THE TRACH WAS REPLACED.

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

  MAUDE report 21357143 ↗
• 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 20260814 ↗
• 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 19939328 ↗
• MalfunctionJun 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S BALLOON "RUPTURED" DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538504 ↗
• MalfunctionJun 5, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE INFLATION LINE OF THE TRACHEOSTOMY TUBE WAS DAMAGED TO THE FLANGE CONNECTION. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19472437 ↗
• MalfunctionMay 22, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA PILOT LINE HAD LEAKS DURING HOMECARE USAGE WITH A PEDIATRIC PATIENT. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19374290 ↗
• MalfunctionMar 7, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CONNECTION BETWEEN THE TRACHEOSTOMY TUBE'S INFLATION LINE AND THE TUBE "RUPTURED" AND RESULTED IN AN AIR LEAK CONTINUOUSLY FOR ABOUT A WEEK. THE PATIENT HAD A TOTAL OF FOUR TUBE REPLACEMENTS.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 18862597 ↗