Shiley 6DICRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 60884522005284), received between Feb 28, 2018 and Jan 4, 2024 — classified as 1 death, 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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.

• MalfunctionJan 4, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INNER CANNULA WAS FOUND NOT SNAPPED IN PLACE FROM THE PATIENT AND WAS HANGING OUT AFTER A DAY OF PATIENT USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446897 ↗
• DeathApr 26, 2022Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE PATIENT HAD THE DEVICE INSERTED IN (B)(6) 2020. THE TUBE WAS USED DURING HOMECARE FOR 1.5 MONTHS. THE PATIENT HAD OBSTRUCTION FROM FLUIDS. THERE WAS MUCUS WITH EACH COUGH. THE PATIENT NEEDED SUCTION EVERY HOUR. THERE WAS DIFFICULTY WITH THE DEVICE FOR 3 MONTHS. A REPLACEMENT DEVICE MAY HAVE BEEN USED. THE PATIENT PASSED AWAY. THE PATIENT HAD A DIAGNOSIS OF TRAUMATIC BRAIN INJURY.

  Patient problems: Apnea; Cardiac Arrest; Dyspnea; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Skin Inflammation/ Irritation

  MAUDE report 14206778 ↗
• MalfunctionAug 17, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, A COMPLETE FINGER OCCLUSION WAS NOT POSSIBLE BECAUSE THERE WAS AIR LEAKS DUE TO THE "CLIPS" ON THE SIDE OR INNER CANNULA DESIGN. INNER CANNULA WAS REMOVED DURING ASSESSMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331119 ↗
• MalfunctionJun 14, 2019Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, THE DEVICE HAD AN EXTRA PIECE OF PLASTIC THAT PREVENTED THE INNER CANNULA FROM ATTACHING TO THE TRACHEOSTOMY TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8702177 ↗
• InjuryFeb 11, 2019Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE DEVICE¿S INNER CANNULA WAS ¼ BENT AT A DIFFERENT ANGLE FROM THE END AND WAS NOT GOING IN PROPERLY. THE PATIENT ENDED UP PLACING THE OLD INNER CANNULA BACK TO HIS "TRACH" TO RESOLVE THE ISSUE.

  Patient problems: Extubate

  MAUDE report 8327506 ↗
• MalfunctionJan 29, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER,PRIOR TO USE, THE DEVICE INNER CANNULA CURVE ON BOTTOM PART COULD NOT FIT INTO TRACHEOSTOMY. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8287796 ↗
• InjuryApr 25, 2018Crack; Crack

  ACCORDING TO THE REPORTER, THE DEVICE WAS CHIPPED OR CRACKED. THE CUSTOMER REPORTED THAT THERE WAS AN EXTRA PIECE OF PLASTIC STILL ATTACHED UNDER THE CLIP ON ONE SIDE WHICH PREVENTED FROM FULLY ATTACHING THE INNER CANNULA TO THE TRACH TUBE. THE CUSTOMER REPORTED THAT THERE WAS NO KNOWN PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7458784 ↗
• MalfunctionApr 25, 2018Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  ACCORDING TO THE REPORTER, DURING ROUTINE INNER CANNULA CHANGE, AN EXTRA PLASTIC WAS NOTED BENEATH THE WING ON ONE SIDE OF THE CANNULA. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7458655 ↗
• InjuryFeb 28, 2018Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE OF THE DEVICE, AN ISSUE WITH THE CANNULA BEING DEFECTIVE WAS OBSERVED. IT WAS REPORTED THAT THEY LOCK THE CANNULA ON ONE SIDE, AND WHEN LOCKING IT ON THE OTHER SIDE IT APPEARED TO CLIP IN FINE, BUT APPARENTLY IT WAS NOT CATCHING. IT WAS STATED THAT WHEN THE PATIENT COUGHS, THE CANNULA COMES OUT. THE TUBE WAS REMOVED AND REPLACED. THERE WAS NO INJURY AND NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: Extubate

  MAUDE report 7302987 ↗