Shiley 8PERCRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 30884522006709), received between Jan 9, 2018 and Sep 9, 2022 — classified as 2 deaths, 25 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TRACH BROKE FROM ITS SECURING DEVICE. THE PATIENT DESATURATED AND TRACH HAD TO BE REPLACED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 15397297 ↗
• MalfunctionMay 16, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE DEVELOPED AIR LEAK EVEN IT WAS ON HIGH PEAK AIRWAY PRESSURES. IT SEEMED THAT THE AIR WAS LEAKING SLOWLY FROM THE VALVE. THE DEVICE WENT BAD ON POD 4. THE PHYSICIAN NOTED THAT THE TAPER GUARD CUFF WAS POORLY SHAPED AND NOT GETTING ENOUGH "PURCHASE" ON THE TRACHEA DUE TO THE CONE SHAPE, WHILE THE OLD CYLINDER SHAPE DID NOT HAVE THIS ISSUE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 14404335 ↗
• MalfunctionJul 16, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS CHECKED BY A RESPIRATORY THERAPIST (RT) EVERY FOUR HOURS. THE DOCTOR DOING THE ROUNDS NOTICED THE BREAKAGE ABOUT TWO HOURS AFTER THE LAST RT CHECK- THE DEVICE'S FLANGE BROKE AWAY FROM THE OUTER CANNULA. THE DEVICE WAS REMOVED AND REPLACED WITH A DEVICE WITH A DIFFERENT PRODUCT ID. THERE WAS SOME BLEEDING AT THE STOMA SITE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Extubation

  MAUDE report 12184075 ↗
• MalfunctionFeb 10, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PATIENT CAME TO CHANGE METALLIC CANNULA NUMBER 6 BY POLYVINYL TO START A NEW TREATMENT - RADIOTHERAPY, WHEN CHANGING HAD BLEEDING AND TREATMENT DID NOT PROGRESS. IT IS NECESSARY TO PLACE THE PORTEX ON RETURNING FROM RADIOTHERAPY, BLEEDING BACK ONLY BEING POSSIBLE TO PLACE THE METALLIC CANNULA 5 THEN, FORWARDED TO HEAD AND NECK SECTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11306838 ↗
• InjuryOct 31, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S BALLOON WOULD NOT INFLATE FOLLOWING INSERTION INTO THE AIRWAY AND WAS RUPTURED. ANOTHER KIT WITH THIS TRACHEOSTOMY TUBE WAS USED AND THE SAME RESULT OCCURRED. THE PATIENT WAS RE-CANNULATED.

  Patient problems: Extubate

  MAUDE report 10767497 ↗
• InjuryOct 31, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S BALLOON WOULD NOT INFLATE FOLLOWING INSERTION INTO THE AIRWAY AND WAS RUPTURED. ANOTHER KIT WITH THIS TRACHEOSTOMY TUBE WAS USED AND THE SAME RESULT OCCURRED. THE PATIENT WAS RE-CANNULATED.

  Patient problems: Extubate

  MAUDE report 10767496 ↗
• InjuryOct 12, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE CIRCULAR PIECE THAT THE INNER CANNULA CLIPS UNTO BROKE OFF THE FLANGE. THE INNER CANNULA AND VENTILATOR TUBING CONNECTED TO IT WAS SEPARATED FROM THE PATIENT, INHIBITING THE PATIENT'S ABILITY TO BE VENTILATED AND PATIENT DESATURATED TO 75%. THE NURSE WAS ABLE TO REINSERT AIRWAY AND MANUALLY HOLD IT IN. THE PATIENT'S OXYGEN INCREASED AND PATIENT RECOVERED. PATIENT THEN HAD TO UNDERGO AN EMERGENT TRACH CHANGE. IT WAS ALSO REPORTED THAT THE SECOND TRACH BROKE AT THE SAME TIME.

  Patient problems: Extubate; Low Oxygen Saturation

  MAUDE report 10666340 ↗
• InjuryOct 12, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE CIRCULAR PIECE THAT THE INNER CANNULA CLIPS UNTO BROKE OFF THE FLANGE. THE INNER CANNULA AND VENTILATOR TUBING CONNECTED TO IT WAS SEPARATED FROM THE PATIENT, INHIBITING THE PATIENT'S ABILITY TO BE VENTILATED AND PATIENT DESATURATED TO 75%. THE NURSE WAS ABLE TO REINSERT AIRWAY AND MANUALLY HOLD IT IN. THE PATIENT'S OXYGEN INCREASED AND PATIENT RECOVERED. PATIENT THEN HAD TO UNDERGO AN EMERGENT TRACH CHANGE. IT WAS ALSO REPORTED THAT THE SECOND TRACH BROKE AT THE SAME TIME.

  Patient problems: Extubate; Low Oxygen Saturation

  MAUDE report 10666165 ↗
• InjurySep 30, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, AFTER THE PROCEDURE, THE PATIENT WAS STARTED TO DESATURATE AND THE DEVICE HAD AN AIR LEAK REQUIRING FIO2 100% FOR SPO2 90%. IT WAS NOTED THAT THE 8.0 DEVICE TUBE WAS BROKEN. IT WAS ATTEMPTED TO REPLACED PERCUTANEOUS TRACHEOSTOMY, HOWEVER, UNABLE TO PLACE NEW DEVICE TUBE INTO AIR WAY NOTICED SIGNIFICANT AMOUNT OF BLEEDING AND UNABLE TO ADEQUATE OXYGENATE AND VENTILATE LEADING TO SUBSEQUENT BRADYCADIA AND PULSELESS ELECTRICAL ACTIVITY ARREST. CPR WAS INITIATED AND RETURN OF SPONTANEOUS CIRCULATION ACHIEVED WITHIN APPROXIMATELY 2 MINUTES WITH EPINEPHRINE 1MG (X1) AND CALCIUM 1G (X1) GIVEN AFTER ADEQUATE OXYGENATION VIA 7.00 ENDOTRACHEAL TUBE INSERTION. PATIENT EVENTUALLY STABILIZED AND BECAME HEMODYNAMICALLY STABLE. INTUBATION REQUIRED.

  Patient problems: Extubate; Low Oxygen Saturation

  MAUDE report 10610397 ↗
• InjuryAug 6, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PRODUCT'S OUTER WHITE PLASTIC CANNULA WAS FOUND TO BE BROKEN OFF FROM THE COLLAR AND FREELY MOVING IN AND OUT OF THE ANTERIOR NECK TRACT. THE PATIENT HAD UNCONTROLLED DIABETES MELLITUS, HYPERTENSION, ACUTE KIDNEY INJURY, ANEMIA, AND WAS COVID NEGATIVE. HE WAS ADMITTED FOR STROKE/RIGHT SUBCORTICAL INTRACRANIAL HEMORRHAGE. THE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 10375980 ↗
• InjuryAug 5, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE TRACH TUBE BROKE FREE FROM THE CUFF AND WAS FLOATING FREELY IN THE TRACHEA. THE PATIENT HAD A SIGNIFICANT CARDIAC HISTORY INCLUDING RHEUMATIC HEART DISEASE, MECHANICAL MITRAL VALVE REPAIR, BIOPROSTHETIC TARGET VESSEL REVASCULARIZATION, ON ANTICOAGULATION, COVID NEGATIVE, AND WAS ADMITTED FOR STROKE/SUBDURAL HEMATOMA. THE PRODUCT WAS REPLACED.

  Patient problems: Extubate

  MAUDE report 10370056 ↗
• InjuryAug 5, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PRODUCT'S OUTER WHITE PLASTIC CANNULA WAS FOUND TO BE BROKEN OFF FROM THE COLLAR AND FREELY MOVING IN AND OUT OF THE ANTERIOR NECK TRACT. THE PATIENT HAD UNCONTROLLED DIABETES MELLITUS, HYPERTENSION, ACUTE KIDNEY INJURY, ANEMIA, AND WAS COVID NEGATIVE. HE WAS ADMITTED FOR STROKE/RIGHT SUBCORTICAL INTRACRANIAL HEMORRHAGE. THE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 10370013 ↗
• InjuryAug 5, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A BROKEN OUTER CANNULA MIGRATING FROM THE NECK. THE PATIENT WAS POST PARTUM X 1 MONTH (PR E-ECLAMPTIC), COVID NEGATIVE, WITH HYPERTENSION, ADMITTED FOR STROKE/MASSIVE INTRAVENTRICULAR HEMORRHAGE. THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 10369950 ↗
• InjuryAug 3, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE WINGS WHICH SECURE INNER CANNULA TO TRACH FLANGES WAS BROKEN. RE-INTUBATION WAS REQUIRED. IT WAS REPLACED WITH AN IDENTICAL TRACHEOSTOMY TUBE (8.0 CUFFED).

  Patient problems: Extubate

  MAUDE report 10359932 ↗
• InjuryJul 28, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING INTUBATION, THE PATIENT HAD A CARDIAC ARREST WHEN THE DEVICE'S PLATE WAS BROKEN. AFTER NOTICING BREAK, UNABLE TO SECURE INNER CANNULA TO TUBE WITH SIGNIFICANT AIR LEAK. REPLACEMENT OF PERCUTANEOUS TRACHEOSTOMY COMPLICATED BY BLEEDING WITH INABILITY TO PLACE NEW 8.0 CUFFED TRACHEOSTOMY TUBE, THEN 6.0 ENDOTRACHEAL TUBE PLACED WITH INADEQUATE OXYGENATION. THEN INTUBATED THROUGH OROPHARYNX WITH 7.00 ETT (ROCURONIUM, ETOMIDATE).

  Patient problems: Extubate

  MAUDE report 10331376 ↗
• InjuryJul 21, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACH HARDWARE WAS BROKEN AND TRACH PLATE IDENTIFIED TO BE SUTURED AND REMAINED IN PLACE. CARDIOPULMONARY RESUSCITATION(CPR) INITIATED WITH RETURN OF SPONTANEOUS CIRCULATION(ROSC) WITHIN 2 MINUTES. PATIENT WAS SUBSEQUENTLY INTUBATED WITH ENDOTRACHEAL TUBE(ETT), DEFECTIVE TRACH REMOVED, PACKAGING SEQUESTERED AND NEW PERCUTANEOUS TRACH REINSERTED. IN ADDITION THE PATIENT HAD PRE-EXISTING MEDICAL CONDITIONS LIKE HYPERTENSION AND PRIOR STROKE WITH MILD RESIDUAL WEAKNESS ADMITTED WITH ACUTE LEFT MIDDLE CEREBRAL ARTERY SYNDROME(MCA) STROKE IN SETTING OF LEFT SUPRACLINOID INTERNAL CAROTID ARTERY(ICA) OCCLUSION.

  Patient problems: Extubate

  MAUDE report 10302615 ↗
• InjuryFeb 13, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD BROKEN WHITE PIECE ON TOP OF THE FLANGE. IT WAS STATED THAT THE SEPARATION OF WHITE PIECE NOTICED DURING CHANGING OF INNER CANNULA. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 9708985 ↗
• MalfunctionFeb 10, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE FIRST ITEM BALLOON WAS BROKEN OR DAMAGED AND THE 2ND ITEM BALLOON DID NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687456 ↗
• MalfunctionFeb 10, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE FIRST ITEM BALLOON WAS BROKEN OR DAMAGED AND THE 2ND ITEM BALLOON DID NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9686941 ↗
• DeathDec 5, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PERCUTANEOUS TRACHEOSTOMY PROCEDURE, THE DEVICE WAS PLACED ON THE PATIENT AND THE PILOT BALLOON WOULD NOT INFLATE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT HAD COMPLICATIONS NOT RELATED TO THE PLACEMENT OF THE PERCUTANEOUS TRACHEOSTOMY. THE PATIENT DIED SEVEN DAYS AFTER THE PROCEDURE AND WAS NOT BY THE INITIAL TRACHEOSTOMY. THE CAUSE OF PATIENT DEATH WAS UNKNOWN.

  Patient problems: Death; Extubate

  MAUDE report 9420828 ↗
• InjuryDec 5, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE HAD TRACH TUBE THAT BROKE AT THE FLANGE, INNER CANNULA, NO LONGER SECURE AND SLIPPING OUT OF PLACE. TRACH TUBE REQUIRED URGENT CHANGING. CHANGE WAS DIFFICULT UNDER THE CIRCUMSTANCES AND PATIENT WAS IN DISTRESS.

  Patient problems: Extubate

  MAUDE report 9420569 ↗
• MalfunctionOct 25, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE FLANGE BECAME DETACHED FROM THE CANNULA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239671 ↗
• DeathSep 26, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, TRACHEOSTOMY WAS PERFORMED DUE TO POOR VENTILATION TO THE CRITICALLY ILL PATIENT CONNECTED TO MECHANICAL VENTILATION. PREMATURE DISLODGEMENT OF THE TRACHEOSTOMY TUBE WAS OBSERVED AFTER PROCEDURE, THE TUBE WAS REMOVED TO BE REPLACED BUT PATIENT SUFFERED CARDIAC ARREST AND DIED LATER ON. AFTER REMOVING THE TUBE, IT WAS OBSERVED THAT THE ACCESS TO THE TRACHEA WAS NOT ESTABLISHED, THE TRACHEOSTOMY TUBE WAS ORIENTED AGAINST THE RIGHT SIDE OF THE TRACHEA POSTERIOR WALL, CREATING A FALSE PASSAGE, RESULTING IN LOSS OF THE AIRWAY. THERE WAS NO DIFFICULTY EXPERIENCED INSERTING THE DEVICE AND THE TUBE WAS PLACED A FEW HOURS. RESPIRATOR WAS CONNECTED TO THE TUBE WHILE IT WAS IN PLACE.

  Patient problems: Death

  MAUDE report 9122721 ↗
• MalfunctionAug 26, 2019Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE UNIT TRACHEOSTOMY TUBE WAS BROKEN OFF THE FRONT PLATE. THE CUSTOMER STATED END PIECE WAS SEPARATED. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932298 ↗
• InjuryMay 2, 2019Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CAUSED A PRESSURE ULCER BELOW WHERE THE EXTERNAL PILOT CUFF AND UNDER OF THE JUGULAR NOTCH WHEREIN THE EDGE OF THE PLASTIC WAS PRESSING ON THE SKIN. IT WAS ALSO EXPLAINED THAT THE PRESSURE ULCER WAS A LEVEL IV TISSUE NECROSIS THAT MADE THE SKIN BREAKING. THE PATIENT REQUIRED FOR A CHANGE OF DRESSING, A CREAM TO TREAT THE PRESSURE ULCER AND A CANNULA EXCHANGE.

  Patient problems: Extubate; Injury

  MAUDE report 8576081 ↗