Medline Industries, Inc. 00-401824YRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889942784363), received between Jul 2, 2020 and Sep 23, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionSep 23, 2020Break

  IT WAS REPORTED A GUIDEWIRE BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10577994 ↗
• MalfunctionJul 2, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED THE HUB BROKE OFF THE GUIDEWIRE SHEATH WHILE IN THE PATIENT. THE REPORTER STATES THE INCIDENT OCCURRED DURING THE MIDDLE OF A PROCEDURE, "NO REPORT OF INJURY OCCURRED AS WE WERE ABLE TO REMOVE THE BROKEN SHEATH BEFORE IT CAUSED HARM".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10225285 ↗