DeRoyal 30-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00749756037242), received between Aug 7, 2024 and Sep 21, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Device Misassembled During Manufacturing /Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846102 ↗
• MalfunctionSep 21, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846094 ↗
• MalfunctionFeb 11, 2026Material Separation

  A DISTRIBUTING FACILITY REPORTED, "STRING OF THE PATTY COME OFF OF THE ACTUAL PAD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314335 ↗
• MalfunctionFeb 6, 2026Material Separation

  A USER FACILITY REPORTED, "PORTION OF PATTY STRING WAS DETACHED FROM THE PATTY HEAD - STRING WAS SUCTIONED AND HAD TO BE RETRIEVED. COMPLETE PARTS OF PATTY WAS ACCOUNTED FOR DURING COUNTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276641 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "DURING PROCEDURE, CST REQUESTED ADDITIONAL 1/2"X1/2" COTTONOID PATTIES BE OPENED. OPENED AS REQUESTED. SHORTLY AFTER, CST NOTIFIED CIRCULATOR THAT A COTTONOID HAD THE GREEN STRIPE FALL OFF. CIRCULATOR CONFIRMED WITH CST THAT THE COTTONOID CAME FROM THE FRESHLY OPENED COTTONOIDS, AND NOT FROM THE PACK. CST CONFIRMED THE FAULTY COTTONOID WAS FROM THE SEPARATELY OPENED PACK. CST THEN CHECKED ALL THE 1/2" X 1/2" COTTONOIDS ON THE FIELD AND FOUND 1 ADDITIONAL COTTONOID WITH A LOOSE GREEN STRIPE. BOTH FAULTY COTTONOIDS REMOVED FROM THE FIELD, BOTH LOOSE GREEN STRIPES ALSO REMOVED FROM THE FIELD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290505 ↗
• MalfunctionMay 29, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  A DISTRIBUTING FACILITY REPORTED, "NEURURGICAL SPONGE IS NOT RADIOLUCENT DURING X-RAY TAKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106643 ↗
• 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."

  Patient problems: Insufficient Information

  MAUDE report 22055259 ↗
• MalfunctionMay 20, 2025Material Separation; Material Separation

  A DISTRIBUTING FACILITY REPORTED, "EACH PATTIE HAS A STRING AND RADIOLUCENT MARKER. 3 OF THE MARKERS HAD COME AWAY FROM THE PATTIE AND THAT SHOULD NOT HAPPEN. 2 WENT UP INTO THE SUCTION AND 1 WAS RETRIEVED AND PUT IN SPECIMEN POT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054052 ↗
• MalfunctionMay 12, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "THE ONE PATTY THAT WAS USED HAD ONE OF THE RFID GREEN STRIPS COME OFF." THIS HAS BEEN UPDATED TO X-RAY GREEN STRIP AS THERE IS NO RFID STRIP IN THE NEURO SPONGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002779 ↗
• MalfunctionMar 25, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "NURSE NOTICED ONE OF THE NEURO PATTY (.5 X.5) HAD THE RUBBER X-RAY DETECTABLE MATERIAL WAS LOOSE. THIS SHOULD BE INTACT ON TOP OF THE SPONGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691584 ↗
• MalfunctionMar 25, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "X-RAY DETECTABLE STRIP FELL APART FROM SPONGE DURING USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691583 ↗
• MalfunctionFeb 7, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "SEEING THE STRING ON THE NEURO PATTIES IN THE 1/2 X 1/2 SIZE COME LOOSE FROM THE DRESSING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21331672 ↗
• MalfunctionJan 20, 2025Material Separation; Material Separation

  A DISTRIBUTING FACILITY REPORTED, "DEROYAL NEURO PATTIES REF# (B)(4) RADIOPAQUE STRINGS ARE FALLING OFF. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193132 ↗
• MalfunctionJan 20, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "RADIOPAQUE STRINGS ARE FALLING OFF".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193130 ↗
• MalfunctionDec 16, 2024Material Separation; Material Separation

  A DISTRIBUTING FACILITY REPORTED, "DURING A CASE ONE OR THE NEURO PATTY SPONGES CAME APART IN THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20945543 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  THE SPONGES WHEN BEING USED IN THE OR ARE STARTING TO COME APART WHEN USING ON THE PATIENT IN SURGERY. ESSENTIA HAS BEEN USING THESE FOR YEARS AND THIS IS THE FIRST TIME THIS HAS HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931675 ↗