Shiley 18890SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521726734), received between Mar 1, 2022 and Mar 1, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Installation-Related Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2022Installation-Related Problem; Installation-Related Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE DEVICE HAD A LEAKAGE. THE RESPIRATORY THERAPIST (RT) ATTEMPTED TO PUT AIR IN THE CUFF SEVERAL TIMES BUT THE LEAKAGE WAS STILL PRESENT. REINTUBATION WAS REQUIRED WITH LARGER ONE. THE PATIENT WAS PREOXYGENATED WITH 100%. VENTILATOR WAS DISCONNECTED AND A BOUGIE WAS PLACED INTO THE EXISTING TUBE AND REMOVED. THE 9.0 ETT WAS INSERTED OVER THE BOUGIE. AS THE TUBE ADVANCED INTO THE AIRWAY, A RESISTANCE WAS FELT. THE PATIENT SATURATION BEGAN TO DROP INTO THE MID 80S. THE BOUGIE AND TUBE WERE REMOVED FROM THE AIRWAY AND PATIENT WAS BAGGED. THE PATIENT WAS REINTUBATED WITH A 7.5 ETT WHICH WAS SECURED AT 24 AT THE LIP.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 13633654 ↗