microTargeting™ Drive System MT-DS-00352Recalls & reported problems

Fhc, Inc. · microTargeting Drive System Contains: -microTargeting Manual Drive -Drive Mount and Guide -microTargeting(TM) Sterilization Case -Verfication Probe -DBS Measurement Fixture -DBS Adapter for microTargeting(TM) Drive - Accessories kit -Matrix Guide Bushings -Lumen Cleaning Tool · Class 2

All models of microTargeting Drive System (3)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

7 other recalls cover devices cleared under the same FDA submission (K011775); they may or may not involve this specific model.

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.

Recalls naming this device

May 10, 2018Terminated
The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
Z-2345-2018 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011775. One submission often covers many models, so check the product and lot details in each record.

Z-0312-2025 · Oct 4, 2024 · Open, Classified
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neu
Z-2346-2018 · May 10, 2018 · Terminated
microTargeting" Drive System, Product Number MT-DS-01
Z-2356-2018 · May 10, 2018 · Terminated
microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
Z-2348-2018 · May 10, 2018 · Terminated
microTargeting" Drive System, Product Number 66-ZD-MD-01
Z-2355-2018 · May 10, 2018 · Terminated
microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
Z-2347-2018 · May 10, 2018 · Terminated
microTargeting" Drive System, Product Number 66-ZD-MD
Z-0895-05 · Mar 14, 2005 · Terminated
FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)

Device details

UDI-DI	`00873263003527`
Brand	microTargeting™ Drive System
Model	MT-DS-00352
Catalog no.	MT-DS
Company	Fhc, Inc.
Product code	HAW · Neurological stereotaxic Instrument
Class	Class 2
FDA submission	K011775
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Neurosurgical micro targeting drive

A calibrated guide mechanism used by a surgeon to manually operate a Z-axis positioner which allows extremely accurate placement of a single or multiple microelectrodes, stimulation electrodes, probes, instruments, or implantable devices, along a chosen track during neurosurgery on the brain. It is intended to be used with a neurosurgical stereotactic system. It typically consists of a metal, graduated frame along which an instrument holder traverses (e.g., approximately 50 mm) by adjustment of a graduated knob that revolves a fine pitched lead screw (e.g., one revolution of the knob will advance the drive by 1 mm). Some types can have an electrical motor attached for motorized drive.

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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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
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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