NeuroPace Cortical Strip Lead KitRecalls & reported problems across all models

We found 4 models of NeuroPace Cortical Strip Lead Kit by Neuropace, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Dec 10, 2015 and Jun 23, 2026 — classified as 18 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NeuroPace Cortical Strip Lead Kit problems

NeuroPace Cortical Strip Lead Kit models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NeuroPace® Cortical Strip Lead Kit CL-325-10-K

  Implanted brain stimulator for epilepsy
  9 reports
• NeuroPace® Cortical Strip Lead Kit CL-335-10-K

  Implanted brain stimulator for epilepsy
  7 reports
• NeuroPace® Cortical Strip Lead Kit CL-325-10-K

  Implanted brain stimulator for epilepsy
  5 reports
• NeuroPace® Cortical Strip Lead Kit CL-335-10-K

  Implanted brain stimulator for epilepsy
  2 reports

Recent NeuroPace Cortical Strip Lead Kit adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Signal Artifact/Noise

  ON (B)(6) 2026, THE PATIENT HAD A ROUTINE BATTERY REPLACEMENT. SHORTLY AFTER THE REPLACEMENT, THE LEFT TEMPORAL (NON-MESIAL) CORTICAL LEAD SHOWED A FLAT SIGNAL. ON (B)(6) 2026, THE PATIENT HAD AN ADDITIONAL SURGERY TO REINSERT THE LEAD INTO THE CONNECTOR AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25597232 ↗
• 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 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT HAD LEFT TEMPORAL LOBE RESECTION AND LEAD IMPLANT. ON (B)(6) 2025, THE PATIENT REPORTED POOR WOUND HEALING, FLUID DISCHARGE, AND INFECTION. ON (B)(6) 2025, THE PATIENT HAD A WOUND WASHOUT AND LEAD EXPLANT. AFTER SURGERY THE PATIENT WAS ADMINISTERED A TRIPLE ANTIBIOTIC REGIMEN (ORAL AND IV)THE TREATING CENTER GAVE THE DIAGNOSIS OF A DEEP INCISIONAL INFECTION.

  Patient problems: Bacterial Infection; Fluid Discharge; Impaired Healing

  MAUDE report 24063341 ↗
• 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 ↗
• MalfunctionApr 19, 2023Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  DURING AN ECOG REVIEW PERFORMED ON 08/09/2022, AN UNUSUAL SIGNAL WAS OBSERVED, INDICATIVE OF A LEAD BREAK ON THE RIGHT SUB-TEMPORAL STRIP. THE BREAK APPEARS TO HAVE OCCURRED AROUND FEB 2022. THERE WAS NO CHANGE IN TREATMENT, THE DOCTOR REPORTED THAT THE FRACTURE DID NOT SEEM TO AFFECT EFFICACY OF THE RNS SYSTEM. TROUBLESHOOTING INCLUDED PALPITATION OF THE LEAD WHICH RESULTED IN HIGH IMPEDANCE AND SIGNAL ARTIFACT. NO KNOWN TRAUMA WAS REPORTED, AND A CAUSE WAS UNABLE TO BE DETERMINED. THE LEAD WAS SECURED WITH A BURR HOLD COVER. THE LEAD HAS BEEN IMPLANTED 1.7 YEARS AT TIME OF LEAD BREAK OBSERVATION. ON (B)(6) 2023 THE PATIENT UNDERWENT A LEAD REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769935 ↗
• 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 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED THAT THE PATIENT WAS PICKING AT THE RNS SYSTEM INCISION SITE AND A PORTION OF AN UNCONNECTED RNS SYSTEM LEAD WAS EXPOSED. THERE WAS SOME EVIDENCE OF EROSION AT THE INCISION SITE; HOWEVER IT IS UNCLEAR IF THIS WAS DUE TO THE EXCORIATION OF THE INCISION SITE. ONCE EXPOSED, THE PATIENT CUT THE LEAD NEAR THE DOG-BONE PLATE (A NON-NEUROPACE PRODUCT USED TO SECURE THE LEAD TO THE SKULL), REMOVED THE EXPOSED PORTION OF THE LEAD, AND DISCARDED THE PRODUCT. THE RESIDUAL PORTION OF THE CUT LEAD REMAINS IMPLANTED. AS THE LEAD WAS NOT CONNECTED TO THE RNS SYSTEM, THE PATIENT'S RESPONSIVE STIMULATION TREATMENT WAS NOT AFFECTED BY THE EVENT. TREATMENT INCLUDED WOUND CLEANING AND ANTIBIOTICS.

  Patient problems: Twiddlers Syndrome

  MAUDE report 11405447 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION WITH THE RNS SYSTEM ON (B)(6) 2021. IMMEDIATELY POST-IMPLANT, THE PATIENT WAS NOT ABLE TO MOVE HIS CONTRALATERAL SIDE. SYMPTOMS STARTED AS DISTAL LEFT HAND WEAKNESS THAT PROGRESSED TO INVOLVE THE LEFT ARM AND LEG. A POSTOP CT WAS PERFORMED AND INDICATED A HEMORRHAGE NEAR THE LOCATION OF THE LEADS (APPROXIMATELY 1CM AWAY), LOCATED IN THE MOTOR CORTEX. THE SURGEON HYPOTHESIZED THAT THE BLEED MAY HAVE BEEN DUE A VESSEL WHICH RUPTURED FROM THE PRESSURE OF THE IMPLANTED LEADS AFTER SURGICAL CLOSURE. NO SURGICAL INTERVENTION WAS NECESSARY AND BY THE EVENING AFTER SURGERY, THE PATIENT DEMONSTRATED IMPROVEMENT IN ARM MOVEMENT. MULTIPLE POST-OP CTS WERE TAKEN AND NO CHANGES WERE SEEN IN THE SIZE/LOCATION OF THE BLEED. THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL.

  Patient problems: Intracranial Hemorrhage; Paresis

  MAUDE report 11346626 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 THE PATIENT PRESENTED WITH SEVERE HEADACHES AND SPEECH DIFFICULTY WHICH HAD STARTED TWO DAYS EARLIER. A BRAIN MRI WAS PERFORMED WHICH IDENTIFIED A LEFT PARIETAL INTRACEREBRAL HEMORRHAGE LOCATED BELOW OF THE SITE OF THE RNS SYSTEM LEADS). DIAGNOSED AS AN ACUTE CEREBRAL HEMORRHAGE. TREATMENT INCLUDED PROLONGED HOSPITALIZATION.

  Patient problems: Headache; Intracranial Hemorrhage; Speech Disorder

  MAUDE report 11280640 ↗
• InjuryDec 5, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT HAS A PRE-IMPLANT HISTORY OF NON-EPILEPTIC EVENTS WITH BILATERAL SENSORY PHENOMENA WITH NO ELECTROGRAPHIC CORRELATE SEEN ON RECORDED ECOGS AFTER IMPLANT WITH THE RNS SYSTEM. THE SYMPTOMS PROGRESSED POST-IMPLANT FROM BILATERAL SENSORY SYMPTOMS TO DISTAL LEFT HAND WEAKNESS WHICH SPREAD TO INVOLVE THE ENTIRE ARM. DUE TO THE PROGRESSION OF THE SYMPTOMS, THE PATIENT PRESENTED AT THE EMERGENCY DEPARTMENT WHERE A HEAD CT WAS PERFORMED THAT IDENTIFIED AN INTRAPARENCHYMAL HEMORRHAGE LOCATED ADJACENT TO THE UNCONNECTED STRIP LEAD. MULTIPLE MRIS WERE PERFORMED 11/1/2020- 11/4/2020 WHICH INDICATED A CHANGE IN LOCATION OF THE UNCONNECTED STRIP LEAD SINCE INITIAL IMPLANT. ON 11/05/2020 THE PATIENT WAS TAKEN TO THE OR FOR SURGICAL EVACUATION OF THE HEMORRHAGE AND REMOVAL OF THE UNCONNECTED STRIP LEAD.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10953128 ↗
• MalfunctionAug 10, 2020Break; Impedance Problem; Break; Impedance Problem

  DURING A REVIEW OF RNS NEUROSTIMULATOR DATA BY THE TREATING CLINICIAN, ARTIFACT WAS OBSERVED ON THE ECOG RECORDED FROM THE LEFT STRIP LEAD , INDICATING A POTENTIAL LEAD BREAK. AFTER DISCUSSION WITH THE PATIENT, IT WAS DETERMINED THAT THIS SIGNAL CHANGE OCCURRED FOLLOWING A FALL DUE TO A SEIZURE, CONSISTENT WITH THE PATIENT'S PRE-IMPLANT SEIZURE SEMIOLOGY. THE PATIENT WAS SUBSEQUENTLY SCHEDULED FOR A LEAD REPLACEMENT PROCEDURE, WHICH WAS PERFORMED WITHOUT COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10387984 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT INITIAL PLACEMENT OF THE RNS SYSTEM ON (B)(6) 2019. POST-OP, A ROUTINE CT SCAN WAS PERFORMED, WHICH IDENTIFIED A HEMORRHAGE AROUND THE LEFT TEMPORAL CORTICAL STRIP LEAD. THE LEFT CORTICAL STRIP LEAD WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2019, AND ALL OTHER LEADS REMAINED IMPLANTED. NO OTHER DETAILS WERE PROVIDED BY THE TREATING CENTER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9595938 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE PATIENT UNDERWENT RNS SYSTEM PLACEMENT ON (B)(6) 2019. IT WAS COMMUNICATED TO NEUROPACE THAT THE CORTICAL STRIP PLACEMENT WAS IMPEDED DURING THE PROCEDURE DUE TO THE STEREOTACTIC FRAME PLACEMENT. TWO CT SCANS WERE PERFORMED POST-PROCEDURE AND COMPARISON OF THE SCANS INDICATED THAT THE UNCONNECTED STRIP LEAD HAD MIGRATED. THE PATIENT WAS BROUGHT BACK TO THE OR FOR LEAD REPOSITIONING. NO FURTHER INFORMATION WAS PROVIDED BY THE TREATING CENTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252349 ↗

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