Shiley 86394Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884522002035), received between Jan 17, 2020 and Oct 26, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF WAS LEAKING DURING PROCEDURE, BUT THE SURGERY WENT ON. RE-INTUBATION NOT REQUIRED. THERE WAS NO PATIENT HARM.

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

  MAUDE report 15675041 ↗
• InjuryJan 17, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THE DEVICE HAD A CUFF DEFLATION ISSUE. THEY WERE UNABLE TO PULL OUT THE TUBE DUE TO SIGNIFICANT RESISTANCE WHILE BOTH EXTERNAL CUFFS WERE COMPLETELY DEFLATED. IT WAS REVEALED THAT THE PROXIMAL CUFF STILL FILLED WITH SALINE AND WEDGED AGAINST THE CORD THEREBY PREVENTING SAFE EXTUBATION. THEY PERFORMED A PUNCTURE OF THE CUFF WITH SURGICAL MICRO-SCISSORS UNDER DIRECT LARYNGOSCOPY. AFTER SUCCESSFUL PROXIMAL TRACHEAL CUFF PERFORATION, THEY DISCOVERED THAT THE DISTAL TRACHEAL CUFF WAS ALSO FAILED TO DEFLATE AND WAS PUNCTURED IN A SIMILAR FASHION. AFTER THE TUBE WAS SAFELY REMOVED, THE PATIENT WAS RE-INTUBATED USING OTHER BRAND OF ENDOTRACHEAL TUBE.

  Patient problems: Extubate

  MAUDE report 9601135 ↗