microTargeting™ Electrode FC2001-00749Recalls & reported problems
Fhc, Inc. · microTargeting Differential Electrode 5x, D.ZAP(L), Sterile, Array, T=30 for use with Frame, STar or MT Drive · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10873263007492), received between Feb 12, 2020 and Dec 1, 2023 — classified as 2 injuries.
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 Problem2
Patient problems
- Intracranial Hemorrhage2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
WHEN MER ON ONE SIDE WAS COMPLETED AND A TEST STIMULATION WAS USED, IT WAS CONFIRMED THAT THE LEFT SIDE OF THE BODY OPPOSITE TO THE RIGHT HEMISPHERE WHERE MER WAS PERFORMED COULD NOT BE MOVED AS THE PATIENT WANTED IT TO. THE PATIENT'S RESPONSE WAS NOT CLEAR AND THE PATIENT'S CONDITION WAS STRANGE, SO A DBS OPERATION WAS DISCONTINUED, AND WHEN A CT SCAN WAS PERFORMED; A HEMORRHAGE IN THE BRAIN WAS CONFIRMED. SUBSEQUENTLY, THE BLOOD WAS REMOVED VIA EMERGENCY CRANIOTOMY. THE PROGRESS HAS NOT BEEN CONFIRMED YET. THE PRODUCT WAS DISCARDED AND LOT NUMBER IS UNKNOWN. THE DOCTOR HAS CONFIRMED THERE WAS NO ISSUE WITH OUR PRODUCT, THIS HAPPENS AS A SIDE EFFECT OF BRAIN SURGERY.
Patient problems: Intracranial Hemorrhage
MAUDE report 18245509 ↗InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN EVENT AT HOSPITAL IN (B)(6) INVOLVING FHC PRODUCT MODEL FC2001 ON (B)(6) 2020. EVENT WAS DESCRIBED AS FOLLOWS: "AT THE TIME OF INTRAOPERATIVE STIMULATION, THERE WAS ABNORMALITY IN THE PATIENT'S CONDITION. THE PRODUCT WAS EXTRACTED IMMEDIATELY AND IT WAS DISCONTINUED. AFTER THAT, CT SCAN WAS PERFORMED. INTRACEREBRAL HEMORRHAGE OCCURRED DURING INTRAOPERATIVE STIMULATION. THE PATIENT WAS IN THE CONDITION OF UPPER LIMB HEMIPLEGIA." REPORT NOTES THAT THE PATIENT IS ALIVE-WITH INJURY AND THIS WAS A FACTOR OF SURGICAL PROCEDURE. THE REPORT ALSO NOTES THAT THE EVENT HAD NO RELATION WITH THE PRODUCT. PRODUCT WAS DISCARDED BY USER AND WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Intracranial Hemorrhage
MAUDE report 9699816 ↗
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- Spencer Probe Depth Electrode SD06R-AP58X-000Ad-Tech Medical Instrument Corporation · ELECTRODE, DEPTH1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
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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