Shiley 110885Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 40884521068255), received between Feb 22, 2023 and Feb 22, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K082520); they may or may not involve this specific model.

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.

• MalfunctionFeb 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IT WAS FOUND THAT WATER ACCUMULATED IN THE CUFF OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417335 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082520. One submission often covers many models, so check the product and lot details in each record.

• Z-1625-2016 · Apr 4, 2016 · Terminated
  Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
• Z-1626-2016 · Apr 4, 2016 · Terminated
  Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..