Shiley 5.5PLCF (UDI 10884521103580)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521103580), received between Dec 12, 2022 and Mar 2, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-INSPECTION TESTING, THE TRACHEOSTOMY TUBE'S CUFF HAD LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501261 ↗
• MalfunctionJun 12, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD AIR LEAKAGE DURING INTUBATION. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19519097 ↗
• MalfunctionMay 24, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, IN PREPARATION FOR THE PROCEDURE, THE TRACHEOSTOMY TUBE'S BALLOON WAS LOPSIDED (UNSYMMETRICAL) DURING INF LATION. THE USER RAN INTO A SIMILAR INCIDENT WITH THE NEXT BALLOON, AS IT WOULD NOT INFLATE AT ALL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397530 ↗
• MalfunctionMay 24, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, IN PREPARATION FOR THE PROCEDURE, THE TRACHEOSTOMY TUBE'S BALLOON WAS LOPSIDED (UNSYMMETRICAL) DURING INF LATION. THE USER RAN INTO A SIMILAR INCIDENT WITH THE NEXT BALLOON, AS IT WOULD NOT INFLATE AT ALL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397483 ↗
• InjuryFeb 21, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF LEAKED, AND THE PATIENT HAD DECREASED SPO2. REPEATED MANUAL BAGGING, SQUEEZING, AND SUCTIONING DID NOT HELP, AS SPO2 DROPS TO THE SECOND HALF OF 80% WHEN CONNECTED TO THE RESPIRATORY SYSTEM. THE TUBE WAS REPLACED, THE REMOVED TUBE WAS PLACED IN WATER AND INJECTED WITH AIR, THEN THE CUFF BECAME SMALLER WHEN A LIGHT PINCHING PRESSURE WAS APPLIED.

  Patient problems: Hypoventilation; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 18753325 ↗
• MalfunctionFeb 20, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF LEAKED DURING USE BUT THE TUBE STILL USE INSPITE OF THE ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18743864 ↗
• MalfunctionFeb 9, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S PILOT LINE HAD A CRACKED AT THE BASE AND LEAKED AIR DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18681494 ↗
• MalfunctionJan 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE DURING PATIENT USE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 18509715 ↗
• MalfunctionDec 29, 2023Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF BROKE AND HAD AN AIR LEAK DURING PATIENT USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18422633 ↗
• MalfunctionJul 20, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S BALLOON VALVE AND CUFF DID NOT STAY INFLATED DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17368026 ↗
• MalfunctionJun 9, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE TRACH'S LUMEN TUBE BECAME CLOGGED WITH SECRETIONS AFTER SIX DAYS OF USE AND GOT REPLACED. THE TUBE LUMEN CLOGGED WITH SECRETIONS AGAIN AFTER NINE DAYS OF USE AND WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17101256 ↗
• MalfunctionMar 14, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF INFLATION SEAL HAD A LEAK FROM THE CUFF INFLATION TUBE AT THE POINT OF JUNCTION WITH THE FLANGE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 16537853 ↗
• MalfunctionDec 12, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, IN THE CANNULA A RUPTURE WAS FORMED THAT GENERATED A LEAK, AND THE CANNULA ITSELF DID NOT REMAIN CUFFED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958860 ↗