NeuroPace® Cortical Strip Lead Kit CL-335-10-K (UDI 00855547005304)Recalls & reported problems
Neuropace, Inc. · The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw. · Class 3 · Implant
All models of NeuroPace Cortical Strip Lead Kit (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855547005304), received between Apr 19, 2023 and Jan 13, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Impedance Problem” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Impedance Problem1
- Signal Artifact/Noise1
Patient problems
- Bacterial Infection1
- Fluid Discharge1
- Impaired Healing1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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