Shiley 86114Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884522000147), received between Oct 23, 2019 and Jan 13, 2026 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (14 reports).

1 other recall cover devices cleared under the same FDA submission (K871204); they may or may not involve this specific model.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Use of Device Problem

  IT WAS REPORTED THAT THERE WERE ERRORS WITH PROPER INFLATION OF THE ENDOTRACHEAL TUBE'S CUFFS. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24059599 ↗
• MalfunctionApr 4, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF WAS STIFF AND DIFFICULT TO INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047866 ↗
• MalfunctionJul 7, 2023Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF REQUIRED A LOT OF AIR (PRESSURE) TO BE FULLY INFLATED, IT WAS NOT POSSIBLE TO CONFIRM THE CUFF PRESSURE WHEN CUFF WAS INFLATED AND THE CUFF WAS DEFORMED UPON INFLATION BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283266 ↗
• MalfunctionApr 25, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE WAS CHECKED PRIOR TO USE AND THERE WAS NO LEAK BUT IT REQUIRED MORE AIR THAN OTHER BRAND. DURING INTUBATION, THE DEVICE WAS FILLED WITH 15CC AIR AND A LEAK WAS NOTED. ANOTHER 15CC OF AIR WAS ADDED BUT THERE WAS STILL CONTINUOUS LEAK. THE TUBE WAS REMOVED AND NO RUPTURE WAS NOTED. REINTUBATION WAS PERFORMED WITH ANOTHER BRAND WITHOUT ISSUE.

  Patient problems: Unintended Extubation

  MAUDE report 14192806 ↗
• MalfunctionDec 2, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF, PILOT BALLOON AND INFLATION LINE HAD AN AIR LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916063 ↗
• MalfunctionApr 14, 2021Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF INFLATION/DEFLATION ISSUE. THE PATIENT REQUIRED A CHANGE OF THE OROTRACHEAL TUBE, DUE TO A PROBABLE RUPTURE IN THE PNEUMO.

  Patient problems: Unintended Extubation

  MAUDE report 11666079 ↗
• InjuryOct 19, 2020Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE AND SHOWED GURGLING AND LEAKAGE DUE TO THE VENTILATOR SCREEN. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 10699838 ↗
• InjurySep 25, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, PATIENT WAS INTUBATED WITH 8.5 ,THE TUBE HAD 100% LEAKAGE. THE CUSTOMER STATED THEY MOBILIZE ADEQUATE VOLUMES WITHOUT DESATURATIONS. THE BALLOON WAS INFLATED FROM THE PNEUMOTAPONATOR BUT THE BALLOON WAS DEFLATED AGAIN. THE DOCTOR ON DUTY WAS INFORMED TO CHANGE THE TUBE, IT IS CHANGED TO A CATHETER FOR COLD INTUBATION, THE TUBE IS CHANGED FOR 8.5. THE PATIENT WAS MOBILIZING ADEQUATE VOLUMES IN THE VENTILATOR BUT IT REMAINS DE SATURATED. FOR WHAT WAS CHANGED AGAIN BY MEANS OF LARYNGOSCOPY, PATIENT WAS INTUBATED, WHICH IS SET AT 25 CM, IS CONNECTED AGAIN TO A MECHANICAL VENTILATOR UNDER THE ESTABLISHED PARAMETERS. INTUBATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 10590697 ↗
• InjurySep 17, 2020Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, PATIENT WAS INTUBATED WITH 8.5 ,THE TUBE HAD 100% LEAKAGE. THE CUSTOMER STATED THEY MOBILIZE ADEQUATE VOLUMES WITHOUT DESATURATIONS. THE BALLOON WAS INFLATED FROM THE PNEUMOTAPONATOR BUT THE BALLOON WAS DEFLATED AGAIN. THE DOCTOR ON DUTY WAS INFORMED TO CHANGE THE TUBE, IT IS CHANGED TO A CATHETER FOR COLD INTUBATION, THE TUBE IS CHANGED FOR 8.5. THE PATIENT WAS MOBILIZING ADEQUATE VOLUMES IN THE VENTILATOR BUT IT REMAINS DE SATURATED FOR WHAT WAS CHANGED AGAIN BY MEANS OF LARYNGOSCOPY, PATIENT WAS INTUBATED, WHICH IS SET AT 25 CM, IS CONNECTED AGAIN TO A MECHANICAL VENTILATOR UNDER THE ESTABLISHED PARAMETERS. INTUBATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 10551257 ↗
• InjurySep 4, 2020Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD AN AUDIBLE LEAKAGE DETECTED BY THE FAN. THE PNEUMATIC BALLOON WAS INFLATED WITH A GAUGE AND INTRODUCED A 2CM TUBE BUT THE LEAKAGE WAS STILL AUDIBLE. THE BALLOON WAS FOUND NOT INFLATING OR DEFLATING. A REPLACEMENT OF A TUBE HAS BEEN DONE TO THE PATIENT.

  Patient problems: Extubate

  MAUDE report 10492420 ↗
• InjuryAug 26, 2020Use of Device Problem; Defective Component; Gas/Air Leak; Use of Device Problem; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE THREE DEVICES HAD AIR LEAK WITH HERNIATION OF THE PNEUMATIC PLUG. THE PATIENT WAS REINTUBATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10452767 ↗
• InjuryAug 26, 2020Use of Device Problem; Defective Component; Gas/Air Leak; Use of Device Problem; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE 3 DEVICES HAD AIR LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10452762 ↗
• InjuryAug 26, 2020Use of Device Problem; Defective Component; Gas/Air Leak; Use of Device Problem; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE 3 DEVICES HAD AIR LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 10452758 ↗
• InjuryFeb 20, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE UNIT HAD NOT ENOUGH CUFF AIR. IT WAS STATED THAT WHEN THE TUBE WAS REPLACED, THE CUFF INFLATED WITH THE CHANGED TUBE WITHOUT ANY PROBLEM. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 9731911 ↗
• MalfunctionDec 12, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9457475 ↗
• MalfunctionOct 23, 2019Material Separation; Use of Device Problem; Material Split, Cut or Torn; Material Separation; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A BROKEN CUFF AND IT WAS DESCRIBED THAT THE BALL HAD NOT BLOWN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9228280 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K871204. One submission often covers many models, so check the product and lot details in each record.

• Z-1318-2023 · Feb 10, 2023 · Open, Classified
  COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal in