Shiley 60XLTCDRecalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 20884522028193), received between Mar 22, 2017 and Apr 17, 2026 — classified as 1 death, 11 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (12 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USE, WHEN THE TUBE WAS TESTED, A HOLE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918715 ↗
• MalfunctionAug 28, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE TRACH BECAME DETACHED FROM THE FLANGE. THE BLUE ATTACHMENT ON THE TRACH SNAPPED AND WAS UNABLE TO CONNECT BACK ON TO THE TRACH FLANGE. THE BEDSIDE RN HELD THE TRACH IN PLACE TO KEEP AIRWAY PATENT AND AN EMERGENT TRACHEOSTOMY EXCHANGE HAD TO BE PERFORMED.

  Patient problems: Unintended Extubation

  MAUDE report 22913508 ↗
• MalfunctionAug 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRACH WAS BROKEN AND THE ENT AT BEDSIDE GLUED THE BROKEN PIECE. THE RN TURNED THE PATIENT AND THE TRACH CAME OUT. THE RN REPLACED BROKEN TRACH IN AIRWAY AND HELD IN PLACE WITHOUT SIGNIFICANT EVENTS. IT WAS STATED THAT THE TRACH WAS REBROKEN IN THE SAME PLACE, AND THE MISSING PIECE OF BLUE PLASTIC AND GLUE WAS UNABLE TO BE LOCATED.

  Patient problems: Unintended Extubation

  MAUDE report 22913415 ↗
• InjuryAug 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED INCREASED SHORTNESS OF BREATH WHILE USING A TRACHEOSTOMY TUBE. THE TUBE WAS FOUND BROKEN AT THE BLUE FLANGE CONNECTIONS ON BOTH SIDES, AND PARTS OF THE BROKEN TUBE WERE DISCOVERED UNDER THE TRACH GAUZE. THE EVENT OCCURRED IN A HOSPITAL SETTING.

  Patient problems: Dyspnea; Hypoventilation

  MAUDE report 22889018 ↗
• MalfunctionAug 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE OF THE ENDOTRACHEAL TUBE, IT REQUIRED RE-INFLATION 4 TIMES. THERE WAS AN INTERMITTENT AIR LEAK WITH VARIABLE TIDAL VOLUMES. THE TUBE WAS REPLACED AND UPON REMOVAL OF TRACH, CUFF WOULD NOT REMAIN INFLATED.

  Patient problems: Unintended Extubation

  MAUDE report 22795985 ↗
• MalfunctionMay 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE PROCEDURE, A BALLOON OF THE TRACHEOSTOMY TUBE FAILED TO INFLATE AND COULD NOT BE USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22044484 ↗
• MalfunctionMay 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING TRACHEOSTOMY TUBE EXCHANGE, THE CUFF OF THE NEW TRACHEOSTOMY TUBE "RUPTURED". THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22027613 ↗
• MalfunctionApr 11, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE USE OF THE TRACH, THE PILOT BALLOON WAS FOUND DAMAGED, AND THE CUFF DID NOT INFLATE WHEN THE CANNULA WAS PLACED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832234 ↗
• MalfunctionMar 2, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT DURING USE, THE TRACHEOSTOMY TUBE'S INNER CANNULA WAS FOUND TO BE UNSECURED WITH INNER CANNULA FLANGE NO LONGER ATTACHED TO INNER CANNULA. THE INNER CANNULA WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501262 ↗
• MalfunctionFeb 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BREAKAGE OF TRACHEOSTOMY TUBE AT THE NECK FLANGE DURING PATIENT USE INVOLVING THE 6.0MM XLT TRACH. THE ISSUE OCCURRED IN A HOSPITAL SETTING. THE PATIENT ARRIVED WITH THE TRACHEOSTOMY TUBE ALREADY IN PLACE, ORIGINATED FROM A DIFFERENT HOSPITAL. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21367241 ↗
• InjuryJan 10, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT DURING A ROUTINE PATIENT CHECK, THE FLANGE OF THE TRACHEOSTOMY TUBE DISCONNECTED FROM THE TUBE WHILE IN USE WITH ONE PIN WAS BROKEN. THE PATIENT, WHO WAS ON A VENTILATOR EXPERIENCED DISTRESS AND BLEEDING FROM THE TRACHEOSTOMY SITE THROUGHOUT THE NIGHT. THE PATIENT DID NOT HAVE ANY UNUSUAL AIRWAY ANATOMY, AND A TRACH CLEANING KIT WAS USED FOR CLEANING THE TUBES. THE EVENT DID NOT RESULT IN A DELAY OF ANY PROCEDURE OR SURGERY. FOLLOWING THE REPLACEMENT OF THE TUBE AND AIRWAY MANAGEMENT WITH COLD LAVAGE, THE PATIENT¿S CONDITION STABILIZED AND RECOVERED WITHIN 10 MINUTES.

  Patient problems: Distress; Hemorrhage/Blood Loss/Bleeding; Unintended Extubation

  MAUDE report 21121344 ↗
• MalfunctionAug 31, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AT APPROXIMATELY 1300, THE VENTILATOR ALARMED AND NOTICED THAT THE PRESSURE WAS NOT HOLDING AND VOLUME WAS LOW. ASSESSMENT REVEALED A "RUPTURED" CUFF, WHICH WAS CONFIRMED WITH A LEAK TEST. THE NEXT EMERGENCY TRACK CHANGE WAS DONE AT APPROXIMATELY 1620. THE SECOND TUBE WAS INSERTED AND ALSO BEGAN TO LOSE AIR. THE SAME THING HAPPENED ON THE THIRD TUBE. SWITCHED TO PROXIMAL TRACH TUBE, AND THE PATIENT TOLERATED IT WELL.

  Patient problems: Unintended Extubation

  MAUDE report 20113910 ↗
• MalfunctionAug 31, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AT APPROXIMATELY 1300, THE VENTILATOR ALARMED AND NOTICED THAT THE PRESSURE WAS NOT HOLDING AND VOLUME WAS LOW. ASSESSMENT REVEALED A "RUPTURED" CUFF, WHICH WAS CONFIRMED WITH A LEAK TEST. THE NEXT EMERGENCY TRACK CHANGE WAS DONE AT APPROXIMATELY 1620. THE SECOND TUBE WAS INSERTED AND ALSO BEGAN TO LOSE AIR. THE SAME THING HAPPENED ON THE THIRD TUBE. SWITCHED TO PROXIMAL TRACH TUBE, AND THE PATIENT TOLERATED IT WELL.

  Patient problems: Unintended Extubation

  MAUDE report 20113909 ↗
• InjuryAug 31, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AT APPROXIMATELY 1300, THE VENTILATOR ALARMED AND NOTICED THAT THE PRESSURE WAS NOT HOLDING AND VOLUME WAS LOW. ASSESSMENT REVEALED A "RUPTURED" CUFF, WHICH WAS CONFIRMED WITH A LEAK TEST. THE NEXT EMERGENCY TRACK CHANGE WAS DONE AT APPROXIMATELY 1620. THE SECOND TUBE WAS INSERTED AND ALSO BEGAN TO LOSE AIR. THE SAME THING HAPPENED ON THE THIRD TUBE. SWITCHED TO PROXIMAL TRACH TUBE, AND THE PATIENT TOLERATED IT WELL.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 20113908 ↗
• InjuryAug 21, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, AT APPROXIMATELY 0400, THE VENTILATOR ALARMED AND OBSERVED THAT THE PILOT BALLOON WAS COMPLETELY DEFLATED. SEVERAL ATTEMPTS WERE MADE TO ADD AIR TO THE CUFF; HOWEVER, THE PATIENT WAS UNABLE TO GET VOLUMES, AND THE CUFF FAILED TO HOLD PRESSURE. AN EMERGENCY TRACH CHANGE WAS DONE. THE ORIGINAL TRACH WAS TESTED VIA WATER, AND A RUPTURED CUFF WAS CONFIRMED. AT APPROXIMATELY 1050, THE SAME ISSUE HAPPENED WITH THE SAME TYPE OF TUBE, AND AN EMERGENCY TRACH CHANGE WAS ALSO PERFORMED.

  Patient problems: Hypoventilation; Insufficient Information; Unintended Extubation

  MAUDE report 20023683 ↗
• InjuryAug 17, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, AT APPROXIMATELY 0400, THE VENTILATOR ALARMED AND OBSERVED THAT THE PILOT BALLOON WAS COMPLETELY DEFLATED. SEVERAL ATTEMPTS WERE MADE TO ADD AIR TO THE CUFF; HOWEVER, THE PATIENT WAS UNABLE TO GET VOLUMES, AND THE CUFF FAILED TO HOLD PRESSURE. AN EMERGENCY TRACH CHANGE WAS DONE. THE ORIGINAL TRACH WAS TESTED VIA WATER, AND A "RUPTURED" CUFF WAS CONFIRMED. AT APPROXIMATELY 1050, THE SAME ISSUE HAPPENED WITH THE SAME TYPE OF TUBE, AND AN EMERGENCY TRACH CHANGE WAS ALSO PERFORMED.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 19998753 ↗
• InjuryJul 8, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, A LEAK WAS FOUND FROM THE PATIENT'S STOMA, AND THE VENTILATOR WAS NOT HOLDING PRESSURES AND V OLUMES. AN EMERGENCY TRACH CHANGE WAS DONE, AND A NEW TRACHEOSTOMY TUBE WAS INSERTED ACCORDINGLY. THE PATIENT TOLERATED THE PROCEDURE WELL AND FULLY RECOVERED. A LEAK FROM THE CUFF WAS DETECTED FROM THE OLD TRACHEOSTOMY TUBE THAT WAS REMOVED AND RECOVERED.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 19696435 ↗
• MalfunctionJun 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF WAS DAMAGED WHEN IT WAS TRIED TO INFLATE DURING THE DEVICE CHECKUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621118 ↗
• InjuryJul 21, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE WAS "RUPTURED" AFTER 10 DAYS OF BEING USED. THE VENTILATOR ALARM BECAUSE THE PATIENT HAD LOW TIDAL VOLUMES, LOW MINUTE VENTILATION, AND LOW PRESSURES. AN EMERGENCY TRACH CHANGE HAD TO BE PERFORMED WITH THE SAME SIZE.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 17375332 ↗
• MalfunctionJun 9, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACH'S PILOT BALLOON WAS LEAKING DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17100723 ↗
• MalfunctionJun 9, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY'S PILOT BALLOON WAS LEAKING DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17100663 ↗
• MalfunctionJun 9, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY'S PILOT BALLOON WAS LEAKING DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17098784 ↗
• MalfunctionJul 28, 2022Material Discolored; No Apparent Adverse Event; Material Discolored; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD COSMETIC DAMAGE. DISCOLORATION WAS PHYSICALLY SEEN ON THE PRODUCT. THE PACKAGE WAS NOT TORN OR DAMAGED IN ANY WAY. THERE WAS NO CUT, TEAR OR HOLE OBSERVED. THE CUFF WAS NOT TESTED PRIOR TO USE. IT WAS NOTED THAT THE PRODUCT WAS NOT STORED IN DIRECT SUNLIGHT OR EXPOSED TO DIRECT SUNLIGHT FOR EXTENDED PERIODS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15123027 ↗
• MalfunctionJul 7, 2022No Apparent Adverse Event; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD COSMETIC DAMAGE. THERE WAS NO CUT, TEAR OR HOLE OBSERVED. THE CUFF WAS NOT TESTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945785 ↗
• MalfunctionJul 7, 2022No Apparent Adverse Event; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD COSMETIC DAMAGE. THERE WAS NO CUT, TEAR OR HOLE OBSERVED. THE CUFF WAS NOT TESTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945750 ↗