STar™ Drive MA 70-ZD-MA-00216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00873263002162), received between Nov 6, 2024 and Nov 6, 2024 — classified as 1 death.

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-2351-2018 · 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.

• DeathNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 30, 2024 FHC WAS CONTACTED BY NEUROSURGERY PROGRAM COORDINATOR AT EVERGREEN HEALTHCARE REPORTING THAT THEY HAD 3 PATIENTS RECENTLY WHO UNDERWENT DBS SURGERIES THAT DEVELOPED INFECTIONS. IN THE COURSE OF INVESTIGATING THESE ISSUES, THEY FOUND THAT ONE OF OUR STAR DRIVES WAS USED IN EACH SURGERY. THE FACILITY IS REVIEWING ALL THE POTENTIAL FACTORS AND THAT INCLUDES INSPECTION OF ALL EQUIPMENT. AS SUCH, THE HOSPITAL REQUESTED A REVIEW OF PROCESSING OF THE PRODUCT FROM FHC FIELD TECHNICIANS WITH THEIR STAFF. ADDITIONALLY, THEY NOTED THAT THEY WOULD BE SENDING THE PRODUCT TO FHC FOR PREVENTIVE MAINTENANCE BECAUSE IT WAS OVERDUE. ON 11/5/2024 FHC RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE HOSPITALS NEUROSURGERY PROGRAM COORDINATOR: 1. (B)(6) 2024 LEAD PLACEMENT, PRESENTED TO ED WITH S/S OF INFECTION ON (B)(6), REMOVAL OF LEAD ON (B)(6). STAPH AUREUS, SERRATIA MARSESCENS. PT UNDERWENT COURSE OF IV ANTIBIOTICS 2. ON (B)(6) 2024 LEAD PLACEMENT, (B)(6) REPORTS S/S OF INFECTION, (B)(6) REMOVAL OF LEAD. COAG NEG STAPH AND NORMAL SKIN FLORA, YEAST. COURSE OF IV ANTIBIOTICS 3. ON (B)(6) 2024 LEAD PLACEMENT, (B)(6) S/S OF INFECTION, SERRATIA MARSESCENS. LEAD REMOVAL (UNKNOW

  Patient problems: Post Operative Wound Infection

  MAUDE report 20624834 ↗

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-2349-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
• Z-2357-2018 · May 10, 2018 · Terminated
  microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
• 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-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