DeRoyal 30-154Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756037808), received between Mar 18, 2022 and May 20, 2025 — classified as 1 injury, 2 malfunctions.

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

• InjuryMay 20, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "FIBRE TISSUE HAD TO BE REMOVED FROM BRAIN TISSUE. LENGTH OF DELAY UNKNOWN."

  Patient problems: Insufficient Information

  MAUDE report 22055267 ↗
• MalfunctionApr 21, 2022Material Separation; Material Separation

  (B)(4) 1/4 X 1/4 NEURO PATTIES WERE USED. THE SURGICAL TECHNOLOGIST NOTED THAT THE X-RAY DETECTABLE LINE IN A PATTY HAD FALLEN OFF ONTO THE SURGICAL BACK TABLE AFTER THE PATTY WAS REMOVED FROM THE PATIENT. PROCEDURE: LUMBAR LAMINECTOMY, NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14168337 ↗
• MalfunctionMar 18, 2022Detachment of Device or Device Component; Device Fell

  DURING PROCEDURE, 1/4 X 1/4 NEURO PATTIES WERE USED. THE SURGICAL TECHNOLOGIST NOTED THAT THE X-RAY DETECTABLE LINE IN A PATTY HAD FALLEN OFF ONTO THE SURGICAL BACK TABLE AFTER THE PATTY WAS REMOVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 13807898 ↗