Shiley 86551Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20884521211671), received between Mar 11, 2019 and May 24, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2024Disconnection; Disconnection

  ACCORDING TO THE REPORTER, DURING USE, THE CONNECTION BETWEEN THE ENDOTRACHEAL TUBE AND VENT TUBING WAS PULLED DUE TO THE WEIGHT OF THE CIRCUIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397553 ↗
• MalfunctionDec 20, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT VALVE HAD IRREGULARITIES WHEN INFLATED BASED ON THE VIDEO PROVIDED, BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369354 ↗
• MalfunctionDec 20, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT VALVE HAD IRREGULARITIES WHEN INFLATED BASED ON THE VIDEO PROVIDED, BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369301 ↗
• MalfunctionMay 5, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE BALLOON ON THE ENDOTRACHEAL TUBE DEFLATED IMMEDIATELY AFTER IT HAS BEEN INFLATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877537 ↗
• MalfunctionJan 24, 2022Use 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, THE CUFF OF THE DEVICE HAD A BREAKAGE AND THE TUBE REINFORCED WITH BALLOON. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 13333700 ↗
• InjuryMay 19, 2021Defective Component; Appropriate Device Problem Term/Code Not Available; Defective Component; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE WAS PRE-TESTED, IT FUNCTIONED NORMALLY AND WAS USED ON PATIENT. THREE DAYS AFTER INTUBATION, THE VENTILATOR HAD LOSS OF TIDAL VOLUME AS NOTED BY PHYSICIAN. THE DEVICE WAS CHECKED AND WAS FOUND DYSFUNCTIONAL AND A NEW TUBE WAS REQUIRED. IT WAS FOUND THAT PNEUMOTRACHEAL TUBE AND PNEUMATIC PLUG IN THE TUBE WAS RUPTURED. THE PATIENT DID NOT PRESENT COMPLICATIONS ASSOCIATED WITH THE MEDICAL DEVICE, BUT THE DIAGNOSIS WAS SEPSIS OF PULMONARY ORIGIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 11848698 ↗
• MalfunctionFeb 25, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS GOING TO BE USED, IT WAS BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378726 ↗
• MalfunctionFeb 23, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE DEVICE'S CANNULA PILOT LINE HAD LEAKS. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11367209 ↗
• MalfunctionDec 10, 2019Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW LEVEL DISINFECTION. THERE WAS A BREAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9446132 ↗
• InjuryDec 4, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF BREAKAGE. ORO TRACHEAL TUBE CHANGE WAS PERFORMED, REMOVED AND WAS INTUBATED. THE PATIENT WAS ADMITTED TO SURGERY RECOVERY ROOM, CONSCIOUS, ALERT WITH GOOD RESPIRATORY PATTERN UNDER RESIDUAL EFFECTS OF GENERAL ANESTHESIA WITH OXYGEN SUPPORT.

  Patient problems: Extubate

  MAUDE report 9410925 ↗
• MalfunctionMar 11, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE UNIT HAD POPPED OFF WITH EACH BREATHE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409221 ↗