Shiley 3.5PCF (UDI 20884521779690)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20884521779690), received between Jun 23, 2021 and Jul 8, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE TRACH TUBE'S CUFF DID NOT DEFLATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25747122 ↗
• MalfunctionMay 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USE INSPECTION, IT WAS FOUND THAT THE TRACH TUBE'S CUFF COULD BE INFLATED NORMALLY, BUT COULD NOT BE DEFLATED AND CONTRACTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029924 ↗
• MalfunctionOct 30, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S PILOT VALVE WITHERED AND COULD NO LONGER BE FILLED. THE TRACH WAS REPLACED.

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

  MAUDE report 20569136 ↗
• MalfunctionFeb 28, 2024Use of Device Problem; Manufacturing, Packaging or Shipping Problem; Use of Device Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE WAS UNABLE TO MAINTAIN PRESSURE WHEN PRE-TESTED. IT WAS ALSO STATED THAT THE TUBE WAS A FAILURE OUT OF BOX. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18804063 ↗
• MalfunctionMar 9, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 16515842 ↗
• MalfunctionFeb 8, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CUFF LOST PRESSURE THAT MADE THE BABY UNCOMFORTABLE. THE BABY STARTED MAKING NOISES WHILE BREATHING, BUT ONCE THE CUFF WAS INFLATED AGAIN, THE NOISE STOPPED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 16329742 ↗
• InjuryMar 28, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS USED FOR 3 WEEKS THEN BEGAN TO LEAK AIR FROM THE CUFF REQUIRING MORE FREQUENT REINFLATION. REPLACEMENT WAS DONE BUT THE NEW DEVICE WOULD NOT INFLATE PROPERLY. AFTER A WHILE, WAS ABLE TO MANAGED TO GET SOME AIR IN BUT THEN COULD NOT GET IT BACK OUT. EVENTUALLY, MANAGED TO DEFLATE THE CUFF AND WAS ABLE REMOVED IT (THAT SAME DAY) AND REPLACED IT WITH A NEW ONE.

  Patient problems: Aspiration/Inhalation; Unintended Extubation

  MAUDE report 13930698 ↗
• InjuryMar 28, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE WAS USED FOR 3 WEEKS THEN BEGAN TO LEAK AIR FROM THE CUFF REQUIRING MORE FREQUENT REINFLATION. REPLACEMENT WAS DONE BUT THE NEW DEVICE WOULD NOT INFLATE PROPERLY. AFTER A WHILE, WAS ABLE TO MANAGED TO GET SOME AIR IN BUT THEN COULD NOT GET IT BACK OUT. EVENTUALLY, MANAGED TO DEFLATE THE CUFF AND WAS ABLE REMOVED IT (THAT SAME DAY) AND REPLACED IT WITH A NEW ONE.

  Patient problems: Aspiration/Inhalation; Unintended Extubation

  MAUDE report 13930598 ↗
• MalfunctionOct 13, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AT HOME, THE PRODUCT HAD A CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627725 ↗
• MalfunctionJun 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE PRODUCT'S CUFF WAS BROKEN WHEN TESTING ITS INTEGRITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12052031 ↗