DeRoyal 50-13119Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756248686), received between Jun 1, 2018 and Jun 1, 2018 — classified as 1 malfunction.

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

• MalfunctionJun 1, 2018Break; Material Fragmentation; Material Integrity Problem; Break; Material Fragmentation; Material Integrity Problem

  TOWELS CONTAINED IN A CARDIAC CATH TRAY ARE LINTING. RANDOM LOOSE STRANDS OF THREAD ARE FALLING OFF OF THE TOWELS. THE END USER IS CONCERNED THE LINT OR THREAD COULD END UP IN A HEART CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7561356 ↗