Shiley 86552Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521211681), received between Sep 3, 2019 and Oct 6, 2021 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Defective Component” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, AT THE TIME OF THE NASAL INTUBATION, DYSFUNCTION OF THE PNEUMOTAPONATOR TUBE OF THE 7.5 RINGED TUBE WAS OBSERVED. AN 8.0 WAS REQUESTED WHICH PRESENTS THE SAME PROBLEM. ADEQUATE VENTILATION OF THE PATIENT WAS NOT ACHIEVED.

  Patient problems: Insufficient Information

  MAUDE report 12583674 ↗
• MalfunctionSep 15, 2021Mechanical Problem; Defective Component; Mechanical Problem; Defective Component

  ACCORDING TO THE REPORTER, AT THE TIME OF THE NASAL INTUBATION, DYSFUNCTION OF THE PNEUMOTAPONATOR TUBE OF THE 7.5 RINGED TUBE WAS O BSERVED. AN 8.0 WAS REQUESTED WHICH PRESENTED THE SAME PROBLEM. ADEQUATE VENTILATION OF THE PATIENT WAS NOT ACHIEVED.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12478407 ↗
• MalfunctionOct 7, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE WAS DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10645471 ↗
• MalfunctionFeb 3, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT BITES DOWN THE ENDO TRACHEAL TUBE AND WOULD NOT RETURN TO SHAPE. IT WAS ALSO INDICATED THAT THIS CAUSE WIRE TO BE EXPOSED. THEY REMOVE THE ET TUBE AND PUT IN ANOTHER TO RESOLVE THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 9662876 ↗
• MalfunctionJan 14, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT BITE DOWN THE ENDO TRACHEAL TUBE AND WOULD NOT RETURN TO SHAPE. IT WAS ALSO INDICATED THAT THIS CAUSE WIRE TO BE EXPOSED. THEY REMOVE THE ENDO TRACHEAL TUBE AND PUT IN ANOTHER TO RESOLVE THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 9588661 ↗
• InjuryOct 4, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT BITE DOWN THE ENDOTRACHEAL (ET) TUBE AND WOULD NOT RETURN TO SHAPE. IT WAS ALSO INDICATED THAT THIS CAUSE WIRE TO BE EXPOSED. THEY REMOVE THE ET TUBE AND PUT IN ANOTHER TO RESOLVE THE ISSUE.

  Patient problems: Extubate

  MAUDE report 9156512 ↗
• InjurySep 3, 2019Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING THE SURGICAL PROCEDURE, IN THE PLACEMENT OF THE SEPARATOR OF TONSILS AFTER APPROXIMATELY THREE HOURS, THERE WAS LEAKAGE OF THE VENTILATOR CIRCUIT, INTUBATION, CONNECTIONS AND EVIDENCE OF FRACTURE OF THE TIE IS REVEALED OF THE OROTRACHEAL TUBE MARKED ON ITS BASE, SO THE VENTILATOR CAPACITY WAS LOST REQUIRING RE-INTUBATION, REQUESTING A NEW DEVICE.

  Patient problems: Extubate

  MAUDE report 8958655 ↗