STar™ Drive M/E System ST-DS-ME-00443Recalls & reported problems

Summary

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

1 FDA recall record name this device's identifier.

8 other recalls cover devices cleared under the same FDA submission (K092562); 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 18, 2026.

Recalls naming this device

1. May 10, 2018Class IITerminated

   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-2350-2018 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092562. One submission often covers many models, so check the product and lot details in each record.

• Z-2358-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
• Z-2354-2018 · May 10, 2018 · Terminated
  microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
• Z-2349-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
• Z-2351-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
• Z-2352-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
• Z-2357-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
• Z-0314-2011 · Mar 30, 2010 · Terminated
  Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5 used with the microTargeting and STar Drives Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the
• Z-0312-2011 · Mar 30, 2010 · Terminated
  STar Drive System, Catalog numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives