DeRoyal 89-10501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756363105), received between Dec 12, 2023 and Mar 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Material Puncture/Hole; Material Puncture/Hole

  HOLE IN PACK PRIOR TO OPENING, SUCTION PUNCTURED THROUGH OUTER PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18954115 ↗
• MalfunctionDec 12, 2023Material Puncture/Hole; Contamination /Decontamination Problem; Material Puncture/Hole; Contamination /Decontamination Problem

  HOLE IN BACK TABLE COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310070 ↗