DeRoyal 89-10543Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00749756363525), received between Feb 21, 2023 and Apr 20, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2023Material Puncture/Hole; Material Puncture/Hole

  HOLE IN OUTER WRAPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775414 ↗
• MalfunctionApr 20, 2023Material Puncture/Hole; Material Puncture/Hole

  HOLE IN OUTER WRAPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775409 ↗
• MalfunctionApr 5, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR FOUND IN TOWELS OF STERILE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682352 ↗
• MalfunctionFeb 21, 2023Material Puncture/Hole; Material Puncture/Hole

  HOLE IN PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408643 ↗