Shiley 125041Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 40884522008762), received between Jun 8, 2017 and Feb 22, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deflation 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. How this data works · Data updated Oct 13, 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 22, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE HAD A LEAK AND SLOWLY DEFLATED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16420819 ↗
• MalfunctionApr 19, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE DISTAL CUFF WOULD NOT INFLATE AND HOLD PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11689800 ↗
• MalfunctionJun 8, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING PRETEST, THE CUFF WOULD NOT COMPLETELY DEFLATE. CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6623376 ↗