NeuroPace Depth Lead KitRecalls & reported problems across all models
Neuropace, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 152
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls
- 0
We found 8 models of NeuroPace Depth Lead Kit by Neuropace, Inc. in the FDA's device registry (GUDID). Together they are named in 152 adverse event reports in the FDA's MAUDE database, received between Sep 2, 2015 and Jul 14, 2026 — classified as 68 injuries, 84 malfunctions.
The most frequently reported specific device problem is “Signal Artifact/Noise” (81 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
Reports received per month, all models
Most reported NeuroPace Depth Lead Kit problems
Device problems
- Signal Artifact/Noise81
- High impedance52
- Adverse Event Without Identified Device or Use Problem41
- Impedance Problem35
- Break24
- Positioning Problem3
- Device Slipped2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions79
- No Consequences Or Impact To Patient26
- Bacterial Infection7
- Intracranial Hemorrhage6
- Erosion5
- Hematoma5
- Hemorrhage/Blood Loss/Bleeding5
- Impaired Healing4
NeuroPace Depth Lead Kit models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NeuroPace® Depth Lead Kit DL-330-10-KImplanted brain stimulator for epilepsy30 reports
- NeuroPace® Depth Lead Kit DL-344-10-KImplanted brain stimulator for epilepsy26 reports
- NeuroPace® Depth Lead Kit DL-344-10-KImplanted brain stimulator for epilepsy23 reports
- NeuroPace® Depth Lead Kit DL-330-10-KImplanted brain stimulator for epilepsy22 reports
- NeuroPace® Depth Lead Kit DL-330-3.5-KImplanted brain stimulator for epilepsy21 reports
- NeuroPace® Depth Lead Kit DL-344-3.5-KImplanted brain stimulator for epilepsy12 reports
- NeuroPace® Depth Lead Kit DL-344-3.5-KImplanted brain stimulator for epilepsy12 reports
- NeuroPace® Depth Lead Kit DL-330-3.5-KImplanted brain stimulator for epilepsy6 reports
Recent NeuroPace Depth Lead Kit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Signal Artifact/Noise
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25813526 ↗MalfunctionJul 14, 2026Signal Artifact/Noise; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25813524 ↗MalfunctionJun 30, 2026Signal Artifact/Noise; High impedance
IN FEB 2026, REVIEW OF THE PATIENT ECOG DATA IDENTIFIED SIGNAL ARTIFACT AND HIGH IMPEDANCE ON THE LEFT AMYGDALA DEPTH LEAD, SECURED WITH A DOG BONE WITH LEAD PROTECTION, INDICATIVE OF A LEAD BREAK. ON (B)(6) 2026, THE LEAD WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670892 ↗MalfunctionJun 18, 2026Signal Artifact/Noise; High impedance
ON (B)(6) 2026, REVIEW OF THE PATIENT'S ECOG DATA WAS PERFORMED. THERE WAS EVIDENCE OF A LEAD BREAK ON THE RIGHT MESIAL TEMPORAL DEPTH LEAD SECURED WITH A DOG BONE WITH LEAD PROTECTION, IN THE FORM OF HIGH IMPEDANCES AND FLAT SIGNALS. ON (B)(6) 2026, STIMULATION ON THE RIGHT LEAD WAS TURNED OFF ON (B)(6) 2026. THE LEAD WAS REPLACED ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25550916 ↗InjuryJun 16, 2026Signal Artifact/Noise
ON (B)(6) 2025, SIGNAL ARTIFACTS AND INCREASES IN SATURATIONS WERE OBSERVED ON THE LEFT FRONTAL DEPTH LEAD SECURED WITH A DOG BONE WITH LEAD PROTECTION, PLACED CONTRALATERAL TO THE RNS. PROGRAMMING CHANGES WERE MADE AT THIS TIME. ON (B)(6) 2026, THE LEAD WAS REVISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523809 ↗MalfunctionJun 5, 2026Signal Artifact/Noise; High impedance
ON (B)(6) 2025, EVIDENCE WAS NOTED OF SIGNAL ARTIFACT AND HIGH IMPEDANCE ON THE RIGHT MESIAL TEMPORAL DEPTH LEAD, LONGITUDINAL, SECURED WITH DOG BONE WITH LEAD PROTECTION. THIS LEAD WAS CONNECTED TO AN RNS WHICH WAS IMPLANTED IN THE AREA OF THE BACK OF THE PATIENT. SIGNAL ARTIFACT AND HIGH IMPEDANCE IS INDICATIVE OF A LEAD BREAK. THE LEAD WAS EXPLANTED ON (B)(6) 26.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25417454 ↗InjuryJun 5, 2026Signal Artifact/Noise; High impedance
ON (B)(6) 2025 EVIDENCE WAS NOTED OF SIGNAL ARTIFACT ON THE LEFT MESIAL TEMPORAL DEPTH LEAD, LONGITUDINAL, SECURED WITH DOG BONE WITH LEAD PROTECTION. SIGNAL ARTIFACT IS INDICATIVE OF A LEAD BREAK. THE LEAD WAS EXPLANTED ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25417418 ↗MalfunctionMay 27, 2026Signal Artifact/Noise; High impedance
IN (B)(6) 2024, HIGH IMPEDANCE AND SIGNAL ARTIFACT WAS OBSERVED ON THE PATIENT'S RIGHT MESIAL TEMPORAL DEPTH LEAD (SECURED WITH DOG BONE WITH LEAD PROTECTION, ORTHOGONAL PLACEMENT). THE PATIENT DID NOT REPORT ANY FALLS OR ACCIDENTS. THE LEAD WAS TURNED OFF AT THAT TIME. ON (B)(6) 2026 THE RIGHT MESIAL TEMPORAL DEPTH LEAD WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25306486 ↗MalfunctionMay 21, 2026Signal Artifact/Noise; High impedance
AT THE (B)(6) 2025 DOCTOR APPOINTMENT, SIGNAL ARTIFACT WAS NOTED ON THE LEFT THALAMUS (CM) DEPTH LEAD, PLACED CONTRALATERAL TO THE RNS. THE LEAD IS SECURED WITH A DOG BONE WITH LEAD PROTECTION. STIMULATION WAS DISABLED ON THE LEAD AT THE (B)(6) 2025 APPOINTMENT. HIGH IMPEDANCE WAS NOTED IN (B)(6) 2026 ON THE SAME LEAD. SIGNAL ARTIFACT AND HIGH IMPEDANCE ARE INDICATIVE OF A LEAD BREAK. THE LEAD WAS REPLACED ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249711 ↗MalfunctionMay 21, 2026High impedance
REVIEW OF THE PATIENT ECOG DATA SHOWED HIGH IMPEDANCE ON THE LEFT THALAMUS (CM) DEPTH LEAD (SECURED WITH A BURR HOLE), INDICATING A LEAD BREAK. IT APPEARS THE LEAD WAS DAMAGED DURING THE (B)(6) 2024 ROUTINE REPLACEMENT. THE LEAD WAS REPLACED ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249710 ↗MalfunctionMay 20, 2026Signal Artifact/Noise
IN (B)(6) 2025, UNUSUAL SIGNAL WAS OBSERVED ON THE PATIENT'S RIGHT HIPPOCAMPAL DEPTH LEAD, MOST NOTICEABLY FLATNESS TO THE BLOCK SIGNAL, WHICH IS INDICATIVE OF A LEAD BREAK. THE PATIENT DID NOT REPORT ANY FALLS OR ACCIDENTS, AND HIS LAST CLINICAL SEIZURE WAS REPORTED TO HAVE BEEN IN MID-NOVEMBER, BUT IT WAS VERY BRIEF. TROUBLESHOOTING DURING THE CLINIC VISIT (INCLUDED PRESSING ON THE DEVICE), WAS ABLE TO REPLICATE THE SIGNAL SOMEWHAT WITH EACH PRESS DOWN. NO CHANGE IN PROGRAMMING WAS MADE AT THAT TIME. ON (B)(6) 2026 THE MESIAL TEMPORAL HIPPOCAMPAL RIGHT DEPTH LEAD (SECURED WITH A DOG BONE WITH LEAD PROTECTION, LONGITUDINAL PLACEMENT) WAS EXPLANTED. THE LEAD WAS NOTICED TO BE VISIBLY KINKED DURING THE EXPLANT PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233985 ↗MalfunctionMay 20, 2026Signal Artifact/Noise; High impedance
IN (B)(6) 2024, ARTIFACT AND HIGH IMPEDANCE WAS OBSERVED ON THE PATIENTS RIGHT MESIAL TEMPORAL DEPTH LEAD (SECURED WITH DOG BONE WITH LEAD PROTECTION, ORTHOGONAL APPROACH). THE PATIENT DID NOT REPORT ANY FALLS OR ACCIDENTS. PROGRAMMING CHANGES WERE MADE IN (B)(6) 2024. ON (B)(6) 2026 THE LEAD WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233979 ↗MalfunctionApr 21, 2026Signal Artifact/Noise; High impedance
ON (B)(6) 2024, REVIEW OF THE PATIENT DATA INDICATED HIGH IMPEDANCE AND SIGNAL ARTIFACT WHICH WERE INDICATIVE OF A LEAD BREAK. ON (B)(6) 2026, THE RIGHT THALAMUS (PUL) DEPTH LEAD (SECURED WITH DOG BONE WITH LEAD PROTECTION) PLACED CONTRALATERAL TO THE RNS WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24947696 ↗MalfunctionApr 15, 2026High impedance
ON (B)(6) 2026, THERE WAS EVIDENCE OF A LEAD BREAK ON THE LEFT MESIAL TEMPORAL DEPTH LEAD CONTRALATERAL TO THE RNS DOG BONE WITH LEAD PROTECTION. ECOG REVIEW IDENTIFIED FLAT SIGNAL AND A TILT ALERT. THE UNUSUAL SIGNAL COINCIDES WITH THE DATE THAT THE PATIENT FELL IN THE SHOWER. ON (B)(6) 2026, THE LEAD WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886810 ↗MalfunctionApr 9, 2026Signal Artifact/Noise; High impedance
THE PATIENT REPORTED HE HAD AN ACCIDENT ON HIS BIKE AND THAT HE HIT HIS HEAD. THE LEFT MESIAL TEMPORAL DEPTH LEAD (LONGITUDINAL APPROACH, CONTRA LATERAL TO THE RNS, SECURED WITH DOG BONE WITH LEAD PROTECTION) SHOWED HIGH IMPEDANCES DURING ECOG REVIEW. AN X-RAY SHOWED NO OBVIOUS LEAD ISSUES. THE LEAD WAS REPLACED ON (B)(6) 2026. THE SURGEON NOTED VISIBLE DAMAGE DURING THE EXPLANT PROCESS. THE LEAD WAS DAMAGED DURING THE EXPLANT PROCESS AND WILL NOT BE RETURNED FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24834769 ↗
Other Neuropace, Inc. products
All Neuropace, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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