NeuroPace® Cortical Strip Lead Kit CL-325-10-K (UDI 00855547005311)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00855547005311), received between Aug 30, 2021 and Feb 19, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED A SUBDURAL HEMORRHAGE WHEN THE TEMPORAL NON MESIAL CORTICAL LEAD (SECURED WITH A DOG BONE WITH LEAD PROTECTION) MIGRATED AND RUPTURED A BLOOD VESSEL. THE PATIENT WAS HOSPITALIZED FOR ONE WEEK FOR MONITORING. THE TEMPORAL NON MESIAL CORTICAL LEAD SECURED WITH A DOG BONE WAS EXPLANTED. FURTHER DETAILS WERE NOT MADE AVAILABLE TO NEUROPACE AFTER REPEATED ATTEMPTS TO CONTACT THE TREATING PHYSICIAN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage

  MAUDE report 24393945 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT HAD A SYMPTOMATIC HEMORRHAGE AROUND THE STRIP ELECTRODE COVERING THE LEFT POSTERIOR SUPERIOR TEMPORAL GYRUS. IT APPEARS THE PATIENT HAD MRI PERFORMED ON (B)(6) 2025. THE RESULTS OF THE MRI WERE NOT PROVIDED. THE PATIENT WAS HOSPITALIZED FOR 6 DAYS FOR OBSERVATION. NO SURGICAL EVACUATION WAS NEEDED. NO OTHER TREATMENT WAS INDICATED. NO RESIDUAL NEUROLOGICAL SEQUELAE WERE OBSERVED. THE PHYSICIAN REPORTED THAT HE WAS NOT ENTIRELY CERTAIN THAT IT WAS AN RNS SYSTEM RELATED EVENT, BUT OTHER CAUSES OF HEMORRHAGE HAD BEEN RULED OUT.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 23705977 ↗
• InjuryNov 25, 2025Difficult or Delayed Positioning; Malposition of Device; Difficult or Delayed Positioning; Malposition of Device

  ON (B)(6) 2025 THE PATIENT UNDERWENT RESECTION AND IMPLANT. POSTOPERATIVELY, THE PATIENT EXHIBITED UNSPECIFIED SPEECH ISSUES. A CT SCAN ON (B)(6) 2025 REVEALED A SMALL HEMORRHAGE BENEATH A COILED LEFT FRONTAL STRIP LEAD WIRE. THE WIRE WAS COILED UNDER THE DURA, COMPRESSING A BLOOD VESSEL AND CAUSING CAPILLARY BACKUP, RESULTING IN THE HEMORRHAGE. ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE TO REPOSITION THE WIRE. FOLLOWING SUCCESSFUL REPOSITIONING, VENOUS FLOW WAS RESTORED.". THE LEAD WAS SECURED WITH ADHESIVE, AND THE SKULL WAS CLOSED. AS OF (B)(6) 2025, THE PATIENT WAS RECOVERING WELL.

  Patient problems: Intracranial Hemorrhage; Speech Disorder

  MAUDE report 23647791 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT STARTED TO NOTICE A BOGGY AREA OF FLUID ON HER SCALP AND THEN EXPERIENCED SOME HEARING LOSS. DETAILS ARE UNCLEAR, BECAUSE THE PATIENT WAS SEEN AT YALE AT THIS TIME. ULTIMATELY, A CT WAS COMPLETED. THE CT SHOWED A PSEUDOMENINGOCELE. AT YALE, THE PATIENT UNDERWENT REPAIR OF THE DURA AND DRAINAGE OF THE PSEUDOMENINGOCELE WITH LUMBAR DRAIN PLACEMENT. THE PATIENT NOTICED THE SAME BOGGY AREA AND HEARING LOSS IN THE SPRING OF 2024. A HEAD CT WAS COMPLETED. THE CT SHOWED A PSEUDOMENINGOCELE AROUND THE SAME LEAD. THE PATIENT UNDERWENT REMOVAL OF LEFT TEMPORAL STRIP LEADS X 3. NEW LEFT PULVINAR AND LEFT HIPPOCAMPAL LEADS WERE PLACED. ACCORDING TO THE PA, THE RNS STRIP LEAD ERODED AT THE DURA, THE CHRONIC DURAL OPENING CAUSED A PSEUDOMENINGOCELE TO FORM. THE FLUID DRAINED TOWARD THE EAR AND CAUSED A SENSORINEURAL HEARING LOSS DUE TO THE FLUID BUILDING UP IN THE INNER EAR. THE HEARING LOSS HAS RESOLVED NOW THAT THE FLUID HAS BEEN DRAINED. THE PATIENT IS BACK TO HER BASELINE AND DOING WELL.

  Patient problems: Cerebrospinal Fluid Leakage; Partial Hearing Loss; Swelling/ Edema

  MAUDE report 20066670 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF AN RNS SYSTEM DEPTH LEAD DURING THE INITIAL IMPLANT PROCEDURE. HOWEVER WHEN ATTEMPTING TO OPEN THE DURA FOR PLACEMENT OF A CORTICAL STRIP LEAD, THE PATIENT EXPERIENCED SIGNIFICANT BLEEDING. THE NEUROSURGEON ABANDONED THE PROCEDURE AND EXPLANTED THE DEPTH LEAD. A LARGER CRANIOTOMY WAS CREATED TO RELIEVE PRESSURE ON THE SKIN. POST-WOUND CLOSURE, THE PATIENT WAS SENT FOR A CT SCAN. THE NEUROSURGEON SUSPECTED A VENOUS INFARCT, CONSIDERING THE PATIENT HAS UNDERGONE PREVIOUS CRANIAL SURGERIES (NOT RELATED TO THE RNS SYSTEM) WHICH LED TO SCAR TISSUE AND DURAL ADHESIONS. AS OF (B)(6) 2021 THE PATIENT IS REPORTED TO BE VERY WEAK AND APHASIC.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 12389049 ↗