STar Drive MARecalls & reported problems across all models
Fhc, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 2
We found 3 models of STar Drive MA by Fhc, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2019 and Nov 6, 2024 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).
2 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
STar Drive MA recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-2357-2018 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
- 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-2351-2018 · Root cause: Device Design · Recall details · FDA record ↗
Most reported STar Drive MA problems
Device problems
- Activation, Positioning or Separation Problem1
- Adverse Event Without Identified Device or Use Problem1
- Malposition of Device1
Patient problems
- Facial Nerve Paralysis1
- Post Operative Wound Infection1
STar Drive MA models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- STar™ Drive MA FC8001-00148Neurological stereotaxic Instrument1 recall1 report
- STar™ Drive MA 70-ZD-MA-00216Neurological stereotaxic Instrument1 recall1 death1 report
- STar™ Drive MA FC8001-00635Neurological stereotaxic Instrument1 recall0 reports
Recent STar Drive MA adverse event reports
The 2 most recent reports across all models, 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 ↗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 ↗
Other Fhc, Inc. products
All Fhc, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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