Shiley 70XLTINRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 60884522006731), received between Jul 24, 2019 and Aug 15, 2025 — classified as 1 death, 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT'S SPOUSE ATTEMPTED TO CHANGE THE INNER CANNULA WHEN THE BLUE PART SNAPPED OFF, ON TWO DIFFERENT INNER CANNULAS WITH THE SAME LOT NUMBER. ADDITIONAL INNER CANNULAS WITH A DIFFERENT LOT NUMBER WERE AVAILABLE AND WAS USED TO CHANGE THE INNER CANNULA. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22819615 ↗
• MalfunctionAug 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT'S SPOUSE ATTEMPTED TO CHANGE THE INNER CANNULA WHEN THE BLUE PART SNAPPED OFF, ON TWO DIFFERENT INNER CANNULAS WITH THE SAME LOT NUMBER. ADDITIONAL INNER CANNULAS WITH A DIFFERENT LOT NUMBER WERE AVAILABLE AND WAS USED TO CHANGE THE INNER CANNULA. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22819601 ↗
• MalfunctionJan 17, 2025Crack; Material Separation; Insufficient Device Problem Information; Crack; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN INNER CANNULA CHANGE FOR A PATIENT WITH A TRACHEOSTOMY WHO WAS INVASIVELY VENTILATED, THE BLUE LOCKING MECHANISM ON A SIZE 70 XLTIN INNER CANNULA WAS FOUND TO BE BROKEN AND CHIPPED IN TWO PLACES. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PRODUCT WAS IMMEDIATELY REMOVED FROM SERVICE, AND THE SAME SIZE INNER CANNULA WAS USED WITHOUT FURTHER DEFICIENCIES NOTED.

  Patient problems: Unintended Extubation

  MAUDE report 21176336 ↗
• MalfunctionFeb 6, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE INNER CANNULA HAD A DENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303675 ↗
• MalfunctionFeb 1, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE INNER CANNULA HAD A DENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277322 ↗
• MalfunctionNov 10, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD FAILED IN A VERY ILL PATIENT. THE PHYSICIAN WAS UNABLE TO VENTILATE THE PATIENT AND SATURATION LEVELS DROPPED. THE PATIENT PASSED AWAY.

  Patient problems: Unintended Extubation

  MAUDE report 12791907 ↗
• InjuryFeb 20, 2020Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, HEALTH CARE PROVIDER TOOK THE NEW INNER CANNULA OUT OF PACKAGE TO REPLACE THE PATIENT'S INNER CANNULA. AS THEY WERE INSERTING THE NEW INNER CANNULA INTO THE TRACH THE FLANGE PART OF THE INNER CANNULA SEPARATED FROM THE WHITE PART OF THE INNER CANNULA. THE PATIENT WAS VENTILATED ON PRESSURE CONTROL 18/5, RATE 18, 30%02. PATIENT EXPERIENCED DESATURATION AND SHORTNESS OF BREATH AS THEY WERE DISCONNECTED FROM THE VENTILATOR AND HCP WAS UNABLE TO CONNECT PATIENT TO VENTILATOR UNTIL A NEW INNER CANNULA WAS OBTAINED.

  Patient problems: Extubate; Low Oxygen Saturation

  MAUDE report 9733707 ↗
• InjuryOct 16, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S BLUE PIECE WAS DIFFICULT TO SECURE THE INNER CANNULA AND CAME TOO LOOSE FROM THE TRACHEOSTOMY. INNER CANNULA WAS ATTACHED BUT COULDN'T CLICK IT INTO PLACE AND VENT TUBING WAS ATTACHED. THE PATIENT HAD CHRONIC RESPIRATORY FAILURE.

  Patient problems: Respiratory Failure

  MAUDE report 9197786 ↗
• DeathJul 24, 2019Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, THE INNER CANNULA WAS NOT SEATED ON THE TRACH AND UPON EXCHANGE THE REPORTER SAW THAT IT WAS CRUSHED. PATIENT CEASED TO BREATHE.

  Patient problems: Death; Extubate

  MAUDE report 8822385 ↗