microTargeting™ Platform MP-KIT-P-U4-00594Recalls & reported problems
Fhc, Inc. · microTargeting Four Legged Unilateral Platform, 1x, nonsterile. Patient specific. · Class 2
Data updated Oct 16, 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 00873263005941), received between Aug 29, 2019 and Aug 29, 2019 — 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 16, 2026.
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.
InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PHYSICIAN REPORTED ON (B)(6) 2019 THAT HE ABORTED HIS DBS IMPLANTATION PROCEDURE BECAUSE THE PATIENT WAS HAVING DIFFICULTY FINDING WORDS. THIS PROCEDURE INVOLVED PLANNING WITH FHC'S WAYPOINT NAVIGATOR AND USAGE OF MICROTARGETING PLATFORM. ELECTRODES, CANNULAE AND DRIVE WERE NOT FHC PRODUCTS. ON FOLLOW UP ON (B)(6) 2019, PHYSICIAN INFORMED THAT A POSTOPERATIVE CT SCAN SHOWED AN INTRACRANIAL HEMORRHAGE, AND THE PATIENT WILL NO LONGER BE A CANDIDATE FOR THE SURGERY.
Patient problems: Intracranial Hemorrhage
MAUDE report 8946803 ↗
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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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