STar™ Drive MA FC8001-00148Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00873263001486), received between Aug 29, 2019 and Aug 29, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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-2357-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2019Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  INFORMATION WAS RECEIVED FROM MEDTRONIC - DISTRIBUTOR OF PRODUCT, REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING IMPLANT OF THE PATIENT'S RIGHT LEAD, THE STARDRIVE TOWER WAS NOT ATTACHED TO THE STARDRIVE BODY TO HOLD THE DBS LEAD AT THE CORRECT TARGET. AS A RESULT, THE DEPTH STOP WAS PLACED ON THE DRIVE INCORRECTLY AND THE LEAD TRAVELED DEEPER THAN DESIRED. THE ERROR WAS DISCOVERED AND THE LEAD WAS PLACED ON THE TOWER CORRECTLY AND THE LEAD LOCATION WAS CONFIRMED CORRECT WITH A CT SCAN. IT WAS NOTED THE SURGICAL TEAM WAS INEXPERIENCED AND MISSED A STEP TO PLACE THE TOWER ON THE STARDRIVE. THE REP ALSO NOTED THEY THEMSELVES FAILED TO RECOGNIZE THE STEP WAS MISSED. THE ISSUE WAS RESOLVED. IT WAS NOTED THE PATIENT EXPERIENCED RIGHT EYE SIX NERVE PALSY; THEIR RECOVERY WAS TO BE MONITORED OVER THE NEXT SIX MONTHS. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Facial Nerve Paralysis

  MAUDE report 8946872 ↗

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-2351-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
• Z-2358-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
• Z-2349-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
• Z-2354-2018 · May 10, 2018 · Terminated
  microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
• Z-2352-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
• Z-2350-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
• 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
• 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