Shiley 86226Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884522005798), received between Sep 27, 2017 and Sep 2, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination 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.

• MalfunctionSep 2, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953356 ↗
• MalfunctionSep 2, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO HAVE STICKY RESIDUE ON IT WHEN RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953354 ↗
• InjurySep 27, 2017Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT HAD A "LACERATION ON THE RIGHT CHEEK BY CANNULA FIXATION". NO REQUIRED INTERVENTION OR DEVICE FAILURE WAS REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 6897694 ↗