Shiley 5.0PCF (UDI 10884521103559)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521103559), received between Apr 10, 2022 and Feb 4, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED POST-OPERATIVELY A FEW DAYS AFTER USE OF THE TRACHEOSTOMY TUBE, THE LUER GUARD OF THE PILOT VALVE WAS NOT FIXED (DAMAGED?). THE REPLACEMENT DEVICE WAS CRIMPED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21304652 ↗
• MalfunctionFeb 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED POST-OPERATIVELY A FEW DAYS AFTER USE OF THE TRACHEOSTOMY TUBE, THE LUER GUARD OF THE PILOT VALVE WAS NOT FIXED (DAMAGED?). THE REPLACEMENT DEVICE WAS CRIMPED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21304640 ↗
• MalfunctionOct 29, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S CUFF HAD A LEAK. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20561215 ↗
• 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 20256247 ↗
• 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 20247644 ↗
• MalfunctionJul 8, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-TEST, BOTH 0F THE TRACHEOSTOMY TUBES' CUFFS HAD A LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19693750 ↗
• MalfunctionMay 16, 2024Crack; Crack

  ACCORDING TO THE REPORTER, DURING USE, IT WAS FOUND THAT THERE WAS A CRACK BETWEEN THE TUBE AND THE FLANGE OF THE TRACHEOSTOMY TUBE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19337215 ↗
• MalfunctionApr 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THERE WAS NO PRESSURE FROM THE TRACHEOSTOMY TUBE DURING USE, AND IT WAS BELIEVED THAT THE PRESSURE WAS LEAKING SOMEWHERE, SO THE TUBE WAS REPLACED. A SIMILAR ISSUE WITH THE SECOND TUBE WAS FOUND PRIOR TO USE. IT WAS STATED THAT THERE WAS LEAKAGE AT THE BASE OF THE INFLATION LINE WHEN THE TRACH WAS CHECKED.

  Patient problems: Unintended Extubation

  MAUDE report 19133286 ↗
• MalfunctionApr 18, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS NO PRESSURE FROM THE TRACHEOSTOMY TUBE DURING USE, AND IT WAS BELIEVED THAT THE PRESSURE WAS LEAKING SOMEWHERE, SO THE TUBE WAS REPLACED. A SIMILAR ISSUE WITH THE SECOND TUBE WAS FOUND PRIOR TO USE. IT WAS STATED THAT THERE WAS LEAKAGE AT THE BASE OF THE INFLATION LINE WHEN THE TRACH WAS CHECKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133256 ↗
• MalfunctionApr 5, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INFLATION LINE FELL OFF DURING USE. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19054134 ↗
• MalfunctionApr 4, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INFLATION LINE FELL OFF AT THE PATIENT'S HOME 2 WEEKS AFTER THE TUBE REPLACEMENT. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19043311 ↗
• MalfunctionApr 4, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INFLATION LINE FELL OFF DURING USE. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19042894 ↗
• MalfunctionFeb 19, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT INFLATE, AND IT WAS REPLACED WITH THE SPARE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 18735999 ↗
• MalfunctionFeb 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

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

  Patient problems: Unintended Extubation

  MAUDE report 18677303 ↗
• MalfunctionJan 17, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE FIRST TRACHEOSTOMY TUBE'S PILOT LINE CAME OFF AND THE SECOND TUBE DEVELOPED A CRACK AND AN AIR LEAK DURING USE. IT WAS STATED THAT THERE WAS PHYSICAL DAMAGED AT THE ROOT PART THAT CONNECTS THE PILOT LINE AND THE TUBE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18531704 ↗
• MalfunctionJan 17, 2024Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE FIRST TRACHEOSTOMY TUBE'S PILOT LINE CAME OFF AND THE SECOND TUBE DEVELOPED A CRACK AND AN AIR LEAK DURING USE. IT WAS STATED THAT THERE WAS PHYSICAL DAMAGED AT THE ROOT PART THAT CONNECTS THE PILOT LINE AND THE TUBE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18531697 ↗
• MalfunctionJan 14, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER CANNULA REPLACEMENT, AN AIR LEAK OCCURRED WITHIN A FEW HOURS. WHEN IT WAS CHECKED, IT WAS FOUND THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS NOT INFLATED, AND THE AIR DID NOT ENTER. THE CANNULA WAS REPLACED WITH THE SAME SIZE.

  Patient problems: Unintended Extubation

  MAUDE report 18509687 ↗
• MalfunctionNov 14, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AIR CAME OUT OF THE TRACHEOSTOMY TUBE'S INFLATION LINE DURING USED. WHEN THE PRODUCT WAS CHECKED, A CRACK WAS CONFIRMED. THERE WAS NO PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 18131684 ↗
• MalfunctionJul 21, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD A LEAK DURING PATIENT USE THAT WAS OBSERVED THROUGH VENTILATOR ALARM. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17372436 ↗
• MalfunctionApr 10, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE DEVICE WOULD NOT INFLATE/DEFLATE AND WAS RUPTURED. DESPITE THE BLUE LITTLE CUFF INDICATE CUFF WAS INFLATED, THE MANOMETER SHOWS NO PRESSURE. THERE WAS NO PATIENT HARM.

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

  MAUDE report 14069382 ↗