Shiley 70XLTCDRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20884522028162), received between Apr 27, 2018 and Sep 15, 2025 — classified as 5 injuries, 7 malfunctions.

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

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

  IT WAS REPORTED THAT DURING USE, THE RIGHT SIDE WHERE THE TRACH TUBE SNAPS INTO THE FLANGE WAS THE PIECE THAT WAS FOUND TO BE BROKEN. ONE SIDE OF THE KNOB PART OF THE FLANGE WHERE THE TRACH PIVOTS ON WAS SNAPPED COMPLETELY OFF AND THE OTHER WAS OUT. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 23050865 ↗
• InjurySep 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING USE OF THE TRACHEOSTOMY TUBE, A PIECE OF THE PATIENT'S TRACH WAS FOUND TO BE BROKEN, WHICH CREATED AN UNSTABLE AIRWAY.

  Patient problems: Hypoventilation

  MAUDE report 23033163 ↗
• InjuryJul 8, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT WAS COMPLAINING REGARDING TRACHEOSTOMY TUBE DISCOMFORT AND SHORTNESS OF BREATH (SOB). THE PILOT BALLOON WAS CHECKED, AND IT APPEARED TO BE NOT HOLDING AIR. THERE WAS ALSO AN AUDIBLE LEAK FROM THE STOMA. THE VENTILATOR WAS ALSO NOT HOLDING ADEQUATE VOLUMES. THE EMERGENCY TRACH WAS DONE ACCORDINGLY, AND THE PATIENT TOLERATED THE PROCEDURE WELL AND FULLY RECOVERED. A LEAK WAS DETECTED FROM THE TUBE THAT WAS REMOVED AND RECOVERED.

  Patient problems: Discomfort; Dyspnea; Hypoventilation; Unintended Extubation

  MAUDE report 19696133 ↗
• InjuryMay 26, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT PRODUCED A LOT OF MUCUS AND 8 HOURS AFTER THE SURGERY THE INNER CANNULA WAS REMOVED FOR CLEANING. WHEN TRIED TO REINSERT THE INNER CANNULA, IT GOT STUCK AND UNABLE TO SLIDE IN. WHEN DOCTOR TRIED TO PUSH THE INNER CANNULA IN IT STARTED TO COLLAPSE. DURING THIS TIME THE PATIENT WAS STRUGGLING TO BREATH. DIFFERENT INNER CANNULA WAS TRIED AND THE RESULT WAS THE SAME. A SIZE 6 WAS MANAGED TO PLACED INSIDE THE CANNULA AND THE PATIENT STARTED TO BREATH NORMALLY.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 17014593 ↗
• MalfunctionMay 26, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT PRODUCED A LOT OF MUCUS AND 8 HOURS AFTER THE SURGERY THE INNER CANNULA WAS REMOVED FOR CLEANING. WHEN TRIED TO REINSERT THE INNER CANNULA, IT GOT STUCK AND UNABLE TO SLIDE IN. WHEN DOCTOR TRIED TO PUSH THE INNER CANNULA IN IT STARTED TO COLLAPSE. DURING THIS TIME THE PATIENT WAS STRUGGLING TO BREATH. DIFFERENT INNER CANNULA WAS TRIED AND THE RESULT WAS THE SAME. A SIZE 6 WAS MANAGED TO PLACED INSIDE THE CANNULA AND THE PATIENT STARTED TO BREATH NORMALLY.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 17010563 ↗
• MalfunctionJun 23, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, A PATIENT WITH THE DIAGNOSIS OF COVID-19 HAD A TRACH PLACED ROUGHLY TWO WEEKS AGO. A FEW DAYS AFTER THE INITIAL TRACH CHANGE, THE PATIENT EXPERIENCED LOSS OF TIDAL VOLUME ON THE VENTILATOR. THE TRACH WAS REMOVED, AND IT WAS NOTED THAT THERE WAS DAMAGE TO THE CUFF. THE TRACH WAS REPLACED WITH ANOTHER, WHICH WAS TESTED WITH AIR PRIOR TO INSERTION BUT SUBSEQUENTLY EXPERIENCED CUFF LEAKAGE AS WELL. THE SECOND TRACH WAS REMOVED AND REPLACED. AGAIN, THE CUFF WAS TESTED WITH AIR PRIOR TO INSERTION AND PRESENTLY HAD ANOTHER LEAK BUT HAD BEEN MINIMAL AND MANAGED WITH THE APPLICATION OF AN "INTELLICUFF" WHICH WAS STILL ATTACHED TO THE PILOT BALLOON.

  Patient problems: Unintended Extubation

  MAUDE report 12048760 ↗
• MalfunctionJun 23, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, A PATIENT WITH THE DIAGNOSIS OF COVID-19 HAD A TRACH PLACED ROUGHLY TWO WEEKS AGO. A FEW DAYS AFTER THE INITIAL TRACH CHANGE, THE PATIENT EXPERIENCED LOSS OF TIDAL VOLUME ON THE VENTILATOR. THE TRACH WAS REMOVED, AND IT WAS NOTED THAT THERE WAS DAMAGE TO THE CUFF. THE TRACH WAS REPLACED WITH ANOTHER, WHICH WAS TESTED WITH AIR PRIOR TO INSERTION BUT SUBSEQUENTLY EXPERIENCED CUFF LEAKAGE AS WELL. THE SECOND TRACH WAS REMOVED AND REPLACED. AGAIN, THE CUFF WAS TESTED WITH AIR PRIOR TO INSERTION AND PRESENTLY HAD ANOTHER LEAK BUT HAD BEEN MINIMAL AND MANAGED WITH THE APPLICATION OF AN "INTELLICUFF" WHICH WAS STILL ATTACHED TO THE PILOT BALLOON.

  Patient problems: Unintended Extubation

  MAUDE report 12048712 ↗
• MalfunctionJun 21, 2021Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn; Use of Device Problem; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING SERVICE AND REPAIR, THE DEVICE HAD AN UNKNOWN FAILURE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND LEAKAGE. VISUAL EXAMINATION SHOWED THAT THERE WAS AIR CONTAINED IN THE CUFF BODY. 20MLS OF AIR WAS REMOVED FROM THE CUFF BODY. THE DEVICE WAS INFLATED AND LEAK TESTED UNDER WATER. LEAKAGE WAS NOTED ON THE MAIN BODY OF THE CUFF. FURTHER EXAMINATION SHOWED THAT THERE WAS A CLEAN CUT SLIT IN THE MAIN BODY OF THE CUFF. THE SLIT MEASURED 0.6MM IN LENGTH. THIS TYPE OF DAMAGE WAS INDICATIVE OF THE CUFF BODY COMING IN CONTACT WITH A SHARP UTENSIL OR OBJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038085 ↗
• MalfunctionMar 12, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S BALLOON WAS OBVIOUSLY LEAKING IN A SHORT TIME. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11472417 ↗
• MalfunctionNov 9, 2020Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, WHEN ATTEMPTING TO USE THE TUBE, THE CUFF DID NOT INFLATE DUE TO A HOLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10808479 ↗
• InjuryApr 27, 2018Air Leak; Air Leak

  ACCORDING TO THE REPORTER, TWO TRACH TUBES WERE LEAKING AND UNABLE TO MAINTAIN AIR IN THE BALLOON. THE CUSTOMER REPORTED THAT THERE WAS NO KNOWN PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: Extubate

  MAUDE report 7468811 ↗
• InjuryApr 27, 2018Air Leak; Air Leak

  ACCORDING TO THE REPORTER, TWO TRACH TUBES WERE LEAKING AND UNABLE TO MAINTAIN AIR IN THE BALLOON. THE CUSTOMER REPORTED THAT THERE WAS NO KNOWN PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: Extubate

  MAUDE report 7468612 ↗