Shiley 60XLTCPRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884522027939), received between Jan 31, 2019 and Jan 13, 2026 — classified as 9 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (17 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Use of Device Problem; Obstruction of Flow

  IT WAS REPORTED THAT INTRA-OPERATIVELY, A COUPLE OF TIMES, ADDITIONAL AIR WAS INFLATED TO THE TRACH'S CUFF, AND IT DID NOT INITIALLY SEEM LIKE THIS AIR WAS GETTING IN. ULTIMATELY, THE IMPRESSION WAS THAT THERE WAS A KINK IN THE TUBE BETWEEN THE INFLATION PORT AND THE TRACHEOTOMY CUFF, AND THAT THE AIR WAS LEAKING BACK OUT THROUGH THE INFLATION PORT, RATHER THAN LEAKING OUT THROUGH ANY ISSUE WITH THE CUFF ITSELF, AS THIS CHALLENGE WITH INFLATING AIR WAS SELF-LIMITING. IN ADDITION, A CUFF PRESSURE TESTING PNEUMATIC DEVICE WAS PLACED OVER THE INFLATION PORT, AND IT SEEMED STABLE AND THE PATIENT WAS VENTILATING WELL. TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24059586 ↗
• MalfunctionJul 10, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT DURING USE OF THE TRACHEOSTOMY TUBE WITH DISTAL CUFF, THE TRACHEOSTOMY TUBE CONNECTION BROKE OFF AT THE FLANGE SITE AND COULD NOT BE RESECURED. THE TRACHEOSTOMY TUBE BECAME UNSECURED IN THE PATIENT, AND AN URGENT TRACHEOSTOMY TUBE EXCHANGE WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unintended Extubation

  MAUDE report 22470759 ↗
• MalfunctionNov 5, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TWO TRACHEOSTOMY TUBE'S CUFF WERE LEAKING WHEN PLACED INTO THE PATIENT. WHEN THE TRACH WAS TESTED IN A BUCKET OF WATER, IT WAS LEAKING, AND PINCHING THE CUFF WOULD ACCELERATE THE LEAK. THERE WERE SMALL LEAKS, BUT THE SPOT WHERE IT WAS LEAKING COULD NOT BE FOUND. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 20606274 ↗
• MalfunctionNov 5, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF STARTED LEAKING WHEN PLACED INTO THE PATIENT DURING A TRACH CHANGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 20605869 ↗
• MalfunctionNov 4, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TWO TRACHEOSTOMY TUBE'S CUFF WERE LEAKING WHEN PLACED INTO THE PATIENT. WHEN THE TRACH WAS TESTED IN A BUCKET OF WATER, IT WAS LEAKING, AND PINCHING THE CUFF WOULD ACCELERATE THE LEAK. THERE WERE SMALL LEAKS, BUT THE SPOT WHERE IT WAS LEAKING COULD NOT BE FOUND. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Unintended Extubation

  MAUDE report 20605262 ↗
• InjurySep 26, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, AN ALARM WAS HEARD FOR LOW VENTILATION, AND NOTICED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS DEFLATED AND WAS NOT HOLDING PRESSURE. AN EMERGENCY TRACH CHANGE WAS DONE, AND THE PATIENT WAS STABLE POST-PROCEDURE. THE TEST WAS DONE ON THE OLD TRACH, WHICH WAS CONFIRMED TO BE "RUPTURED CUFF".

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 20313977 ↗
• InjurySep 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, AN ALARM SOUNDED FOR LOW VENTILATION IN THE PATIENT, AND IT WAS NOTICED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS DEFLATED AND WAS NOT HOLDING PRESSURE. AN EMERGENCY TRACH CHANGE WAS DONE, AND THE PATIENT WAS STABLE POST-PR OCEDURE. A TEST WAS DONE ON THE TRACHEOSTOMY TUBE, WHICH CONFIRMED A "RUPTURED" CUFF WITH BUBBLES PRESENT UPON ATTEMPT. THIS WAS THE 4TH TUBE THAT "RUPTURED" IN THE LAST MONTH FOR THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20198744 ↗
• MalfunctionSep 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, AN ALARM SOUNDED FOR LOW VENTILATION IN THE PATIENT, AND IT WAS NOTICED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS DEFLATED AND WAS NOT HOLDING PRESSURE. AN EMERGENCY TRACH CHANGE WAS DONE, AND THE PATIENT WAS STABLE POST-PROCEDURE. A TEST WAS DONE ON THE TRACHEOSTOMY TUBE, WHICH CONFIRMED A "RUPTURED" CUFF WITH BUBBLES PRESENT UPON ATTEMPT. THIS WAS THE 4TH TUBE THAT "RUPTURED" IN THE LAST MONTH FOR THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20198583 ↗
• MalfunctionSep 11, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, AN ALARM WAS SOUNDED FOR LOW VENTILATION IN THE PATIENT, AND IT WAS NOTICED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS DEFLATED AND WAS NOT HOLDING PRESSURE. AN EMERGENCY TRACH CHANGE WAS DONE, AND THE PATIENT WAS STABLE POS T-PROCEDURE. A TEST WAS DONE ON THE TRACHEOSTOMY TUBE, WHICH CONFIRMED A "RUPTURED" CUFF WITH BUBBLES PRESENT UPON ATTEMPT. THIS WAS THE 4TH TUBE THAT "RUPTURED" IN THE LAST MONTH FOR THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20195624 ↗
• InjurySep 10, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, AN ALARM SOUNDED FOR LOW VENTILATION IN THE PATIENT, AND IT WAS NOTICED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS DEFLATED AND WAS NOT HOLDING PRESSURE. AN EMERGENCY TRACH CHANGE WAS DONE, AND THE PATIENT WAS STABLE POST-PR OCEDURE. A TEST WAS DONE ON THE TRACHEOSTOMY TUBE, WHICH CONFIRMED A "RUPTURED" CUFF WITH BUBBLES PRESENT UPON ATTEMPT. THIS WAS THE FOURTH TUBE THAT "RUPTURED" IN THE LAST MONTH FOR THE PATIENT.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 20180388 ↗
• MalfunctionMay 20, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S PILOT BALLOON WAS NOTICED FLAT DURING USE FOR A MINUTE. THE TRACH WAS REPLACED. IT WAS STATED THAT THE AIR LEAK COULD NOT BE SEEN BUT HEARD.

  Patient problems: Unintended Extubation

  MAUDE report 19355483 ↗
• MalfunctionMay 10, 2024Material Separation; Defective Component; Material Separation; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, A PIECE STARTED TO BREAK ON THE TRACHEOSTOMY TUBE WHERE THE INNER CANNULA STICKS OUT. REPLACEMENT OF THE TUBE WAS DONE. IT WAS ALSO MENTIONED THAT THE CUFFED TRACHEOSTOMY TUBE HAD EXTRA LENGTH IN THE PROXIMAL PORTION.

  Patient problems: Unintended Extubation

  MAUDE report 19289068 ↗
• MalfunctionDec 14, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S BALLOON WAS ALREADY POPPED PRIOR TO USAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18330519 ↗
• MalfunctionMay 1, 2023Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT REQUIRED BRONCHOSCOPY DUE TO PERSISTENT HYPOXEMIA, AND THE INNER CANNULA WAS IN PLACE BECAUSE OF THE PATIENT'S CONDITION WHEN THE 5.5 TRACHEOTOMY SCOPE WENT IN AND GOT STUCK DURING THE PROCEDURE. THERE WAS A NEED TO DAMAGE THE SCOPE TO BE ABLE TO REMOVE IT. THE PATIENT WAS ALIVE AND RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844314 ↗
• InjuryDec 29, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE DEVICE HAD A LEAKED WHICH WAS AUDIBLE FROM THE MOUTH. THE PATIENT HAD OXYGEN DESATURATION, HYPERCAPNIC AND VENTILATING POORLY. CUFF PRESSURE WAS TESTED WITH CUFF MANOMETER EVERY SHIFT WITH WHAT WAS FELT TO BE A SLOW ACTIVE LEAK. QUESTIONED INTERMITTENT PROBLEM ASSOCIATED WITH VALVE IN PILOT BALLOON. DUE TO PATIENT INSTABILITY, THE DOCTOR REMOVED TRACH TUBE AND REPLACED WITH ANOTHER.

  Patient problems: Hypoventilation; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 16074898 ↗
• MalfunctionJun 3, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD UNILATERAL VOCAL FOLD PARALYSIS, RIGHT, SECONDARY TO LARYNGEAL NERVE INVOLVEMENT. THE INNER CANNULA OF THE DEVICE HAD KINK.

  Patient problems: Paralysis; Unintended Extubation

  MAUDE report 14597064 ↗
• MalfunctionApr 14, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, WHEN TRYING TO CHANGE THE TRACH DURING LEAK TEST AND AS PART OF PATIENT MAINTENANCE THE PRODUCT FAILED. THERE WAS A HOLE IN THE CUP, BUBBLES WAS FOUND AND IT COULD NOT HOLD ANY PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111306 ↗
• MalfunctionMar 8, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE DEVICE'S BALLOON WAS RUPTURED DURING INSERTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698888 ↗
• MalfunctionMar 8, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S BALLOON WAS RUPTURED DURING INSERTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698811 ↗
• MalfunctionMar 8, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE DEVICE'S BALLOON WAS RUPTURED DURING INSERTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693590 ↗
• MalfunctionMar 8, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S BALLOON WAS RUPTURED DURING INSERTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693517 ↗
• MalfunctionMar 8, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S BALLOON WAS RUPTURED DURING INSERTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693510 ↗
• MalfunctionMar 8, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE BALLOON OF THE DEVICE WAS RUPTURED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693354 ↗
• MalfunctionMar 8, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE BALLOON OF THE DEVICE WAS RUPTURED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693332 ↗
• MalfunctionMar 8, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS NOTED TO HAVE LESS QUALITY AND WEAKER BALLOON. THE BALLOON WAS RUPTURED DURING INSERTION TO A PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693233 ↗