microTargeting™ Electrode FC2001-00126Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10873263001261), received between Nov 27, 2016 and Nov 27, 2016 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage, Subdural1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PRODUCT USED: FC2001, LOT # 221236 - MICROTARGETING ELECTRODE. DURING THE USE OF THE MICROTARGETING ELECTRODE ON (B)(6) 2016, THE PATIENT HAD A CEREBRAL HEMORRHAGE. EVENT WAS DESCRIBED AS FOLLOWS: AFTER A LEAD WAS POSITIONED IN THE RIGHT SIDE, MINIATURE POTENTIAL IN THE LEFT SIDE WAS MEASURED. MULTI-TECHNIQUE METHOD WAS CONDUCTED, AND 2 TRACKS OF CENTER AND POSTERO WERE RECORDED. WAVES COULD NOT BE CONFIRMED AT DEPTH OF STN TARGET (STN WAVES SEEMED TO APPEAR PARTLY BUT WERE UNSTABLE). SN WAVES SEEMED TO BE IDENTIFIED AT PLUS 1.5MM TO 5 MM ON THE POSTERO SIDE. TRACKS WERE CHANGED TO LATTE AND ANTELO TO MEASURE AGAIN. ALTHOUGH IMPEDANCE DECLINED AT 1200 OHMS ON LATTE SIDE AND AROUND 700 OHMS ON ANTELO SIDE, THE PROCEDURE WAS CONTINUED. AT RE-MEASUREMENT, EVEN SMALL TYPICAL BACKGROUND WAVES WERE IDENTIFIED. THE PATIENT EXPERIENCED MOTOR FUNCTION AND CONSCIOUSNESS LEVEL IN DEPRESSION ON THE LEFT SIDE OF THE BODY. THE PROCEDURE WAS ABORTED. CT SCAN IMAGES IDENTIFIED CEREBRAL HEMORRHAGE. THE PATIENT WAS PLACED UNDER MONITORING THE CUSTOMER DID NOT CONSIDER THAT THE REPORTED PRODUCT CAUSED THE EVENT ISSUE.
Patient problems: Hemorrhage, Subdural
MAUDE report 6128176 ↗
Other ELECTRODE, DEPTH devices
- Spencer Probe Depth Electrode SD04R-AP58X-000Ad-Tech Medical Instrument Corporation · ELECTRODE, DEPTH1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- 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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