HI-LINE GD805RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653075621), received between Sep 21, 2021 and Feb 18, 2022 — classified as 1 injury, 1 malfunction.

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

• InjuryFeb 18, 2022Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG THAT A HI-LINE CRANIOTOME CUTTER II (PART # GD805R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS HOSPITALIZED BECAUSE OF "SUDDEN LEFT LIMB DYSFUNCTION FOR MORE THAN ONE (1) HOUR; UNCONSCIOUSNESS AND VOMITING FOR FORTY (40) MINUTES. COMBINED WITH THE MEDICAL HISTORY AND RELEVANT EXAMINATIONS, THE DOCTOR DIAGNOSED AS: 1. RIGHT TEMPORAL LOBE AND BASAL GANGLIA INTRACEREBRAL HEMORRHAGE AND RUPTURE INTO THE VENTRICLE 2. SUBARACHNOID HEMORRHAGE 3. BRAIN HERNIA FORMATION 4. INHALATION PNEUMONIA 5. GRADE 3 VERY HIGH RISK OF HYPERTENSION. ON NOVEMBER 1, 2021, THE PATIENT UNDERWENT INTRAVENOUS INHALATION COMBINED ANESTHESIA, DECOMPRESSION OF RIGHT FRONTOTEMPORAL PARIETAL BONE FLAP ASSISTED BY MICROSCOPE AND MICRO DYNAMIC SYSTEM, REMOVAL OF INTRACEREBRAL HEMATOMA, DRILLING AND DRAINAGE OF RIGHT VENTRICLE. WHEN THE MILLING CUTTER BLADE WAS USED FOR CRANIOTOMY, THE MILLING CUTTER HEAD WAS BROKEN AND THE OPERATION WAS INTERRUPTED. A NEW MILLING CUTTER HEAD WAS REPLACED TO CONTINUE THE OPERATION WITHOUT CAUSING OTHER HARM TO THE PATIENT. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563279 ↗
• MalfunctionSep 21, 2021Fracture; Fracture

  IT WAS REPORTED TO AESCULAP (B)(4) THAT A HI-LINE CRANIOTOME CUTTER II (PART # GD805R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE MILLING CUTTER WAS USED TO DRILL THE SKULL, THE CUTTER HEAD WAS BROKEN BY 0.7 CENTIMETERS (CM). THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510078 ↗