microTargeting™ Electrode 44975Z-00267Recalls & reported problems
Fhc, Inc. · microTargeting(TM) Electrode, sterile, D.Zap(Z), for use with Platform · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00873263002674), received between Feb 3, 2025 and Feb 3, 2025 — classified as 1 death.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Intracranial Hemorrhage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CASE WAS COMPLETED ON (B)(6) 2025 AT (B)(6) MEDICAL CENTER, (B)(6) WITH DR. (B)(6), WHERE A 57 Y/O PATIENT HAD BOSTON SCIENTIFIC LEADS IMPLANTED BILATERALLY IN STN. MER WAS PERFORMED ON BOTH HEMISPHERES SIMULTANEOUSLY USING FHC 44975Z MICROELECTRODES (A SINGLE TRACK PER SIDE) AND A GUIDELINE 4000 LP+ SYSTEM. OTHER FHC PRODUCTS USED DURING THE CASE WERE STARFIX PLATFORM, 66-IT-03P INSERTION TUBES, 66-ST-12P STYLET. PATIENT RESPONDED WELL TO STIMULATION AND O-ARM IMAGING SHOWED ACCURATE TARGETING. POST-OP CT SHOWED NO ABNORMALITIES AND PATIENT WAS DISCHARGED THE SAME DAY OF SURGERY. THE PATIENT WAS DOING WELL AND HAD GONE BACK TO WORK. FACILITY DID NOT RETAIN LOT# OF PRODUCT USED AND DISPOSED OF PRODUCTS. ON 01/16/2025 FHC, INC. REPRESENTATIVE WAS ATTENDING ANOTHER CASE AT (B)(6) MEDICAL CENTER WITH DR. (B)(6) WHERE DURING THE CASE, THE DR. INFORMED THE FHC REP, THAT THE PATIENT THEY OPERATED ON (B)(6) 2025 WAS FOUND DEAD THIS WEEK AND THAT THEY WERE GOING TO CONDUCT AN AUTOPSY TO DETERMINE THE CAUSE OF DEATH. THE AUTOPSY WAS CONDUCTED ON (B)(6) 2025 WHERE AN INTRACEREBRAL HEMORRHAGE (ICH) AT DBS-LEAD ENTRY SITE AND THALAMUS WAS DETERMINED TO BE CAUSE OF DEATH. SINCE POST-OP CT WAS
Patient problems: Intracranial Hemorrhage
MAUDE report 21295201 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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