Shiley 18750SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521620148), received between Dec 9, 2019 and Feb 13, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS RESISTANCE WHEN DEFLATING THE CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24336809 ↗
• MalfunctionJan 11, 2023Defective Component; Material Split, Cut or Torn; Defective Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TIP OF THE TUBE ON THE SLIP JOINT SIDE WAS "RIPPED", AND THE SLIP JOINT CAME OFF INTRAOPERATIVELY. THE TUBE WAS REPLACED WITH A NEW ONE AND PATIENT WAS REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 16136801 ↗
• MalfunctionDec 9, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE COULD NOT BE DEFLATED COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9441139 ↗