NeuroPace® Cortical Strip Lead Kit CL-335-10-K (UDI 00855547005052)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00855547005052), received between Oct 26, 2016 and Jun 23, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 7 most recent of 7 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THE TREATING CENTER NOTED THAT THE END OF THE NEUROPACE STRIP LEAD, IMPLANTED THE DAY PRIOR, WAS PROTRUDING THROUGH THE INCISION SITE. THE LEAD HAD BEEN IMPLANTED DURING THE COMPLETION OF PHASE II MONITORING AND HAD BEEN CAPPED WITH A LEAD CAP. THE SURGEON EXPLANTED THE LEAD AND REPLACED IT WITH A NEW LEAD.

  Patient problems: No Code Available; Patient Problem/Medical Problem

  MAUDE report 8570094 ↗
• InjurySep 6, 2018Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2017 WITH FOUR CORTICAL STRIP LEADS WHICH WERE SECURED TO THE DURA WITH SUTURES; A RNS NEUROSTIMULATOR WAS NEVER IMPLANTED. ON (B)(6) 2018 THE LEADS WERE EXPLANTED TO TREAT AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7853759 ↗
• InjurySep 6, 2018Break; High impedance; Break; High impedance

  THE LEAD WAS REPLACED ON (B)(6) 2018 AS THE READING INDICATED A PROBABLE LEAD FRACTURE. THE SITE WAS NOT SURE IT WAS A LEAD BREAK; HE JUST KNEW THE READINGS APPEARED OFF SO WE ASSUME IT WAS A NICKED. THE DOCTOR DID NOT WANT IT TO BE EVALUATED. THE DOCTOR FELT IT WAS PROBABLY NICKED BY A RESIDENT WHEN IT WAS IMPLANTED. HE SUSPECTED A HAIRLINE FRACTURE. THE X-RAY SHOWED EVERYTHING WAS INTACT THE NEUROSURGEON WAS HESITANT TO REPLACE BECAUSE HE THOUGHT IT COULD HAVE BEEN PHYSIOLOGICAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7853749 ↗
• MalfunctionOct 26, 2016Break; Break

  (B)(6) 2015 THE PATIENT WAS IMPLANTED WITH RNS SN (B)(4) AND TWO CORTICAL STRIP LEADS (SN B)(4) WAS SECURED TO PORT #1 OF THE RNS AND PLACED IN THE LEFT SUB TEMPORAL REGION, SN (B)(4) WAS SECURED TO PORT #2 OF THE RNS AND PLACED IN THE RIGHT SUB TEMPORAL REGION). BOTH LEADS WERE SECURED WITH A TITANIUM DOG BONE. THE DOCTOR PLACED A PIECE OF CATHETER AROUND MIDDLE OF EACH DOG BONE TO CUSHION/PROTECT THE LEAD. ON (B)(6) 2016 DURING A ROUTINE REVIEW OF ECOGS, FCE NOTICED ABNORMAL LOOKING SIGNAL / ARTIFACT ON CHANNELS 1 AND 2 (LEFT SUB TEMPORAL STRIP). THE ABNORMAL ACTIVITY APPEARS TO HAVE STARTED ON (B)(6) 2016, BUT POSSIBLY AS EARLY AS (B)(6) 2016, BUT WITH LESS FREQUENCY. PATIENT VISIT ON (B)(6) 2016, IMPEDANCE MEASUREMENTS WERE TAKEN AND A REAL TIME ECOGS WAS RECORDED. ONE OF THE IMPEDANCE MEASUREMENTS CAME BACK AS INSUFFICIENT CHARGE. DURING REAL TIME ECOG, THE SITE WAS ABLE TO PALPATE ABOVE THE LEFT EAR AND CREATE ARTIFACT. THERE ARE 2 USER SAVED ECOGS IN PDMS FROM (B)(6) 2016 THAT SHOW THIS PHENOMENON. DETECTION AND STIMULATION WERE TURNED OFF ON THE LEFT LEAD. THE RIGHT LEAD HAS DETECTION AND STIMULATION ENABLED. (B)(6) 2016 LEAD REVISION WAS PERFORMED. FCE REPORTED THAT THE EX

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6059281 ↗