Shiley 87480Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10884521815285), received between Nov 12, 2024 and Sep 17, 2026 — classified as 4 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (24 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50811198 ↗
• MalfunctionSep 8, 2026Disconnection

  It was reported that newer endotracheal tubes, particularly the 7.5 mm and 8.0 mm sizes, had an extremely loose tube-to-hub connection. The endotracheal tubes reportedly arrived from packaging with the hub loosely connected. During intraoperative use on a patient, the tube-to-hub connection may disconnect. Condensation within the tube reportedly prevented clinicians from advancing the hub further to achieve a tighter fit. A visual difference was observed between the prior and newer tube-to-hub connections, and it was alleged that the newer design may contribute to an insecure connection and potential disconnection during patient use. There was no patient outcome.

  Patient problems: Insufficient Information

  MAUDE report 50667100 ↗
• MalfunctionAug 19, 2026Material Puncture/Hole; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331092 ↗
• MalfunctionJul 31, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098556 ↗
• MalfunctionJul 28, 2026Gas/Air Leak

  Patient problems: Unintended Extubation

  MAUDE report 50055114 ↗
• MalfunctionJul 2, 2026Disconnection

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S 15MM CONNECTOR FALLS OUT FROM THE CIRCUIT CONNECTED TO THE VENTILATOR VENTILATOR. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 25689693 ↗
• MalfunctionMay 28, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF PRESSURE BEGUN TO DROP THAT WAS MONITORED VIA THE PRESSURE GAUGE. ATTEMPTED TO REINFLATE THE CUFF, HOWEVER, THE PRESSURE COULD NOT BE MAINTAINED WITHIN THE NORMAL RANGE OF 20¿30 CMH2O. THE TUBE WAS SUBSEQUENTLY REPLACED. AS THE CASE WAS NEARLY COMPLETED, THE SECOND TUBE WAS REMOVED AFTER APPROXIMATELY THREE HOURS OF USE, EVEN THOUGH THE CUFF PRESSURE WAS AGAIN FOUND TO HAVE DROPPED BELOW 20 CMH2O, FALLING OUTSIDE THE ACCEPTABLE RANGE. THERE WAS NO PATIENT INJURY. FOR PLI 30: MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE CUFF WAS TORN PLI 40: UNAUTHORIZED RERURN

  Patient problems: Insufficient Information

  MAUDE report 25320650 ↗
• MalfunctionApr 22, 2026Gas/Air Leak; Failure to Seal

  IT WAS REPORTED THAT DURING AN ELECTIVE INDUCTION, THE CUFF OF THE TUBE DID NOT MAINTAIN A SEAL. THE POSITION WAS ALSO CHECKED BEFORE REINTUBATION, AND THE CUFF WAS FOUND TO BE LEAKING WHEN TESTED AFTERWARDS.

  Patient problems: Unintended Extubation

  MAUDE report 24954976 ↗
• InjuryApr 22, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF OF THE TUBE HAD A LEAK THAT RESULTED TO VENTILATION DIFFICULTIES OF THE PATIENT THAT RESULTED TO REINTUBATION.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 24954471 ↗
• InjuryApr 21, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S CUFF HAD AN AIR LEAK, MAKING INSUFFICIENT VENTILATION. ADDITIONAL AIR WAS ADDED, BUT WAS STILL LEAKING. THE PATIENT WAS LARYNGOSCOPED AGAIN TO CONFIRM THAT THE CUFF WAS POSITIONED BELOW THE VOCAL CORDS, AS IT SHOULD BE. WE ADDED MORE AIR TO THE CUFF, BUT IT QUICKLY LEAKED OUT AGAIN. THE PATIENT WAS REINTUBATED WITH AN INCREASED RISK OF ASPIRATION, AND WE HAD TO MASK VENTILATE AND RE-RELAX THE PATIENT. AFTERWARDS, THE CUFF WAS TESTED AND FOUND TO BE LEAKING, AS EXPECTED. NO ADVERSE OUTCOME FOR THE PATIENT.

  Patient problems: Aspiration/Inhalation; Hypoventilation; Unintended Extubation

  MAUDE report 24942212 ↗
• MalfunctionMar 25, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF OF THE TUBE HAD AN AIR LEAK. THE ISSUE WAS RESOLVED BY CONNECTING A CUFF PRESSURE GAUGE. THE AFFECTED TUBE WAS THEN WITHDRAWN. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Unintended Extubation

  MAUDE report 24683779 ↗
• MalfunctionMar 18, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF WAS INFLATED BUT DEFLATED SLOWLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628295 ↗
• MalfunctionMar 12, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF OF THE TUBE HAD AN AIR LEAK. THE ISSUE WAS RESOLVED BY CONNECTING A CUFF PRESSURE GAUGE. THE AFFECTED TUBE WAS THEN WITHDRAWN. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Unintended Extubation

  MAUDE report 24586686 ↗
• MalfunctionMar 12, 2026Disconnection; Failure to Seal

  IT WAS REPORTED THAT THE CUFF ON ENDOTRACHEAL TUBE WAS NOT SEALING PROPERLY DURING USE. THE ISSUE WAS RESOLVED BY REINTUBATION OR BY USING A CUFF PRESSURE MEASURING DEVICE.

  Patient problems: Unintended Extubation

  MAUDE report 24582451 ↗
• MalfunctionMar 11, 2026Disconnection; Failure to Seal

  IT WAS REPORTED THAT THE CUFF ON ENDOTRACHEAL TUBE WAS NOT SEALING PROPERLY DURING USE. THE ISSUE WAS RESOLVED BY REINTUBATION OR BY USING A CUFF PRESSURE MEASURING DEVICE.

  Patient problems: Unintended Extubation

  MAUDE report 24573107 ↗
• InjuryMar 4, 2026Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT POST-OPERATIVELY, WHILE PATIENT WAS STILL UNDER MECHANICAL VENTILATION, AIRWAY EMERGENCY DEVELOPED DUE TO AIRWAY OBSTRUCTION IN ENDOTRACHEAL TUBE WITH INABILITY TO PASS BRONCHOSCOPY THROUGH TUBE WITHOUT FOREIGN BODY OBSTRUCTION. DURING THE VID EOLARYNGOSCOPY, IT WAS REVEALED A KINK ON THE TUBE AT THE LEVEL OF THE OROPHARYNX, AT 17 CM MARKING WITH PATIENT HAVING DIFFICULT VENTILATION WITH TIDAL VOLUME ONLY 60-80 ML AND DESATURATION OCCURRED. KINKING WAS SPONTANEOUS, WITH NO SURROUNDING TISSUE SWELLING AND ADEQUATE SPACE AROUND TUBE. KINKING REMAINED DESPITE MANIPULATION AND NECESSITATED CHANGE OF ENDO-TRACHEAL TUBE. AFTER EXCHANGE OF TUBE, EXAMINATION OF THE KINKED TUBE REVEALED SOFT TEXTURE, EASILY COMPRESSED AND KINKED BY MANUAL MANIPULATION.

  Patient problems: Hypoventilation; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 24510066 ↗
• MalfunctionFeb 27, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING USE, ENDOTRACHEAL TUBE'S CUFF HAD LEAKED. THE LEAK WAS DISCOVERED AFTER THE PATIENT HAD BEEN INTUBATED. IMMEDIATELY AFTER INTUBATION, THE CUFF PRESSURE WAS SET. FIVE TO TEN MINUTES LATER, WE DISCOVERED THAT THE CUFF PRESSURE WAS DECREASING. THIS CONTINUED, AND THEREFORE WE HAD TO FIND ANOTHER TUBE. THE PATIENT WAS REINTUBATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474886 ↗
• MalfunctionFeb 27, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, ENDOTRACHEAL TUBE'S CUFF HAD LEAKED. THE LEAK WAS DISCOVERED AFTER THE PATIENT HAD BEEN INTUBATED. IMMEDIATELY AFTER INTUBATION, THE CUFF PRESSURE WAS SET. FIVE TO TEN MINUTES LATER, WE DISCOVERED THAT THE CUFF PRESSURE WAS DECREASING. THIS CONTINUED, AND THEREFORE WE HAD TO FIND ANOTHER TUBE. THE PATIENT WAS REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 24474830 ↗
• MalfunctionFeb 25, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF PRESSURE BEGUN TO DROP THAT WAS MONITORED VIA THE PRESSURE GAUGE. ATTEMPTED TO REINFLATE THE CUFF, HOWEVER, THE PRESSURE COULD NOT BE MAINTAINED WITHIN THE NORMAL RANGE OF 20¿30 CMH2O. THE TUBE WAS SUBSEQUENTLY REPLACED. AS THE CASE WAS NEARLY COMPLETED, THE SECOND TUBE WAS REMOVED AFTER APPROXIMATELY THREE HOURS OF USE, EVEN THOUGH THE CUFF PRESSURE WAS AGAIN FOUND TO HAVE DROPPED BELOW 20 CMH2O, FALLING OUTSIDE THE ACCEPTABLE RANGE. THERE WAS NO PATIENT INJURY. FOR PLI 30: MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE CUFF WAS TORN FOR PLI 40: MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE CUFF WAS TORN.

  Patient problems: Unintended Extubation

  MAUDE report 24449233 ↗
• MalfunctionFeb 25, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF PRESSURE BEGUN TO DROP THAT WAS MONITORED VIA THE PRESSURE GAUGE. ATTEMPTED TO REINFLATE THE CUFF, HOWEVER, THE PRESSURE COULD NOT BE MAINTAINED WITHIN THE NORMAL RANGE OF 20¿30 CMH2O. THE TUBE WAS SUBSEQUENTLY REPLACED. AS THE CASE WAS NEARLY COMPLETED, THE SECOND TUBE WAS REMOVED AFTER APPROXIMATELY THREE HOURS OF USE, EVEN THOUGH THE CUFF PRESSURE WAS AGAIN FOUND TO HAVE DROPPED BELOW 20 CMH2O, FALLING OUTSIDE THE ACCEPTABLE RANGE. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 24449218 ↗
• MalfunctionNov 5, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE WAS NOT USED FOR INTUBATION ONCE THE MARKS FADED WITH THE DRUG XILONIBSA (SUPERFICIAL ANAESTHESIC BASED IN LIDOCAINE). THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480181 ↗
• MalfunctionNov 5, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT IN A HOSPITAL SETTING, THE ENDOTRACHEAL TUBE'S CUFFS WOULD NOT STAY INFLATED AFTER INSERTION. THE TUBE WAS REMOVED AND REPLACED, BUT THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Unintended Extubation

  MAUDE report 23479967 ↗
• MalfunctionOct 30, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AFTER A WEEK OF INTUBATION, THE ENDOTRACHEAL TUBE'S EXTERNAL MARKERS WERE FADING, AS SHOWN IN THE ATTACHED IMAGE. THE TUBE WAS REPLACED MADE BY OTHER MANUFACTURER. ADDITIONAL INFORMATION RECEIVED, NO LUBRICATOR WAS USED.

  Patient problems: Unintended Extubation

  MAUDE report 23423600 ↗
• MalfunctionOct 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE CUFF MUST HAVE BEEN OVERINFLATED IN THE PATIENT'S TRACHEA AND "BURST". THE TUBE WAS REPLA CED.

  Patient problems: Unintended Extubation

  MAUDE report 23285291 ↗
• MalfunctionSep 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE OF THE ENDOTRACHEAL TUBE, A CUFF LEAK WAS IDENTIFIED. DURING VENTILATION, ABNORMAL AIR LEAKAGE WAS OBSERVED WHEN 6 ML OF AIR WAS INFLATED INTO THE CUFF. ADDITIONAL INFLATION UP TO 10 ML AND TUBE POSITION REASSESSMENT WERE PERFORMED, BUT THE ABNORMAL LEAK PERSISTED. THE ENDOTRACHEAL TUBE WAS REMOVED AND REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS SUBSEQUENTLY TERMINATED. POST-PROCEDURE TESTING OF THE REMOVED TUBE REVEALED CUFF LEAKAGE, AS DEMONSTRATED IN A VIDEO.

  Patient problems: Unintended Extubation

  MAUDE report 23038735 ↗