Shiley 60XLTINRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 60884522006724), received between Dec 4, 2018 and Jan 17, 2025 — classified as 2 deaths, 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2025Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT IN A HOSPITAL SETTING, THE BLUE LOCKING MECHANISM OF THE 60XLTIN WAS FOUND TO BE COMPLETELY BROKEN AND DETACHED FROM THE INNER CANNULA DURING USE. THE DEFECTIVE PRODUCTS WAS IMMEDIATELY REMOVED FROM SERVICE, AND THE SAME SIZE INNER CANNULA WAS USED WITHOUT FURTHER DEFICIENCIES NOTED.

  Patient problems: Unintended Extubation

  MAUDE report 21176279 ↗
• MalfunctionMay 1, 2024Crack; Crack

  ACCORDING TO THE REPORTER, WHEN CHANGING THE TRACHEOSTOMY'S INNER CANNULA THE BLUE PIECE CRACKED AND FELL OFF. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19226077 ↗
• DeathFeb 29, 2024Disconnection; Human-Device Interface Problem; Disconnection; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS PULLING UP ON TRACH AND IT BROKE OFF FROM THE FLANGE. THE TRACH WAS REPLACED, BUT THE PATIENT PASSED AWAY DURING THE REPLACEMENT.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 18807171 ↗
• MalfunctionJan 5, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY INNER CANNULA'S INNER LOCKING RING FELL OFF PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460842 ↗
• MalfunctionNov 4, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE INNER CANNULA WAS NOT FITTED TO THE TRACH TUBE. THE PATIENT TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18070410 ↗
• DeathNov 11, 2021Defective Component; Appropriate Device Problem Term/Code Not Available; Defective Component; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, A COVID PATIENT WAS UNABLE TO BE VENTILATED. RAPID SEQUENCE WAS PERFORMED WITH AN ENDOTRACHEAL TUBE. THE PATIENT ARRESTED WITH MULTIPLE CODES AND PASSED AWAY.

  Patient problems: Cardiac Arrest; Hypoventilation; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 12791925 ↗
• InjuryJan 18, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE INNER CANNULA WAS BENT APPROXIMATELY 2CM FROM THE HUB. ONE PASS OF ROUTINE SUCTION LED TO PEAK PRESSURES THAT NOT ONLY CAUSED VENTILATOR ALARMS, BUT TERMINATED THE BREATH EARLY RESULTING IN LOW TIDAL VOLUMES. THE PATIENT HAD A SLIGHTLY ELEVATED PRESSURES AFTER TRACH CARE. WHEN PRESSED ON THE END OF THIS INNER CANNULA TO RECREATE THE CURVE OF THE TRACH, IT CAUSED PARTIAL COLLAPSE OF THE AIRWAY WHICH WOULD EXPLAIN THE ELEVATED PEAK PRESSURES.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11187864 ↗
• MalfunctionNov 5, 2020Defective Component; Human-Device Interface Problem; Defective Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED HIGH PEAK PRESSURES AND HIGH PRESSURE ALARMS DUE TO ANATOMICAL ABNORMALITY OR ABNORMAL BEND. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10794459 ↗
• MalfunctionNov 2, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, A PERSISTENT HIGH PEAK PRESSURES AND HIGH PRESSURE ALARMS FROM BEND IN THE INNER CANNULA WAS REPORTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information; No Information; Respiratory Failure

  MAUDE report 10771039 ↗
• MalfunctionSep 1, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A HIGH PRESSURE ALARM (PEAK PRESSURES ALARMED FROM 35.5-38CMH2O) BECAUSE THE INNER CANNULA WAS BEND. DECIDED TO CHANGE THE INNER CANNULA. THE CANNULA HAS AN OBVIOUS BEND IN THE SAME SPOT. THE PEAK PRESSURE RESOLVED IMMEDIATELY AFTER IT WAS CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; No Information

  MAUDE report 10478531 ↗
• MalfunctionAug 13, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WERE PERSISTENT HIGH PRESSURE ALARMS (HIGH PEAK INSPIRATORY PRESSURES: 36-42CMH2O), BECAUSE THERE WAS A BEND IN THE INNER CANNULA APPROXIMATELY 2CM FROM THE HUB. WHEN MANIPULATED TO MIMIC THE NATURAL CURVE OF THE TRACHEOSTOMY, THE INNER CANNULA FOLDED IN ON ITSELF AND PARTIALLY COLLAPSED. THE HIGH PRESSURES RESOLVED WHEN THE INNER CANNULA WAS CHANGED.

  Patient problems: Extubate; Unintended Extubation

  MAUDE report 10401288 ↗
• MalfunctionJul 31, 2020Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THERE WERE PERSISTENT HIGH PRESSURE ALARMS (HIGH PEAK INSPIRATORY PRESSURES: 36-42CMH2O), BECAUSE THERE WAS A BEND IN THE INNER CANNULA APPROXIMATELY 2CM FROM THE HUB. WHEN MANIPULATED TO MIMIC THE NATURAL CURVE OF THE TRACHEOSTOMY, THE INNER CANNULA FOLDED IN ON ITSELF AND PARTIALLY COLLAPSED. THE HIGH PRESSURES RESOLVED WHEN THE INNER CANNULA WAS CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10349279 ↗
• InjuryJul 16, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THERE WERE PERSISTENT HIGH PRESSURE ALARMS (HIGH PEAK INSPIRATORY PRESSURES: 35.5-38CMH2O), BECAUSE THERE WAS A BEND IN THE INNER CANNULA APPROXIMATELY 2CM FROM THE HUB. WHEN MANIPULATED TO MIMIC THE NATURAL CURVE OF THE TRACHEOSTOMY, THE INNER CANNULA FOLDED IN ON ITSELF AND PARTIALLY COLLAPSED. THE HIGH PRESSURES RESOLVED WHEN THE INNER CANNULA WAS CHANGED. THERE WAS NO PATIENT INJURY.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10282551 ↗
• InjurySep 25, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER,BRONCHOSCOPE PERFORMED WITH INNER CANNULA INSERTED. THE INNER CANNULA PULLED UP (LIKE AN ACCORDION), JAMMING THE BRONCHOSCOPE AND ENDED UP PULLING UP INTO THE OPENING. HAD TO UNLOCK INNER CANNULA TO REMOVE BRONCHOSCOPE. IT MADE THE INNER CANNULA SHORTEN FROM REGULAR LENGTH. THE BRONCH GOT DAMAGED POST PROCEDURE.

  Patient problems: Injury; No Patient Involvement

  MAUDE report 9121114 ↗
• InjuryJun 18, 2019Contamination of Device Ingredient or Reagent; Human-Device Interface Problem; Contamination of Device Ingredient or Reagent; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USE, WHEN CHANGING INNER CANNULA, IT WAS NOTED THAT THERE WAS SHREDDED OR FALLING APART AT THE END OF IT WHEN REMOVED. THEN, THERE WAS AN AIRWAY ISSUE WHICH REQUIRED THE PATIENT TO UNDERGO BRONCHOSCOPY THROUGH PATIENT TRACHEOSTOMY AND NOTED THAT THERE WERE SEEMED TO BE SMALL PIECES OF PLASTIC AND LOOK AS IF TO BE PIECES OF AN INNER CANNULA IN THE PATIENT'S UPPER AIRWAY. THE PATIENT WAS DECANNULATED.

  Patient problems: Extubate

  MAUDE report 8710379 ↗
• InjuryDec 4, 2018Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PATIENT CAME BACK FROM ENDOSCOPY AND AFTER THE DEVICE WAS PLACED, THE PATIENT DEVELOPED RESPIRATORY DISTRESS. A PLUG WAS SUSPECTED AND THEY TRIED TO BAG AND SUCTION THE PATIENT. THEY WERE UNABLE TO PASS THE SUCTION CATHETER. THE EXISTING INNER CANNULA WAS REMOVED AND FOUND TO HAVE A KINK/DEFORMATION IN THE TUBE THAT SEVERELY LIMITED THE SIZE OF THE INNER LUMEN. ONCE A NEW INNER CANNULA WAS PLACED THEY WERE ABLE TO BAG AND SUCTION PROPERLY AND RETURN THE PATIENT TO BASELINE. THE ORIGINAL INNER CANNULA WAS DETERMINED TO BE THE CAUSE DUE TO DEFORMATION/KINK. NOTHING ACTUALLY OCCURRED WITH THE TUBE. ONLY THE INNER CANNULA WAS NOTED AS THE CAUSE.

  Patient problems: Extubate

  MAUDE report 8128633 ↗