DeRoyal 30-068Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00749756037877), received between Jul 2, 2024 and Jun 11, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 11, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "THE STRING PULLED OFF WHILE ITEM WAS BEING USED ON A PATIENT, USERS VOCALIZED THERE WAS NO ACCIDENTAL CUTTING OR CAUTERY USE AT THE TIME OF FAILURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22188516 ↗
• InjuryMay 20, 2025Material Separation; Material Separation

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

  Patient problems: Insufficient Information

  MAUDE report 22055275 ↗
• InjuryMay 20, 2025Material Separation; Material Separation

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

  Patient problems: Insufficient Information

  MAUDE report 22055268 ↗
• MalfunctionJul 2, 2024Material Fragmentation; Material Frayed; Material Fragmentation; Material Frayed

  THE PRODUCT IS LEAVING BITS OF "LINT" OR PIECES OF COTTON WERE COMING OFF THE COTTONOIDS. IT APPEARED AS IF THERE WERE WHITE PIECES OF HAIR IN THE WOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656517 ↗