Star Drive M/ERecalls & 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 3
We found 3 models of Star Drive M/E by Fhc, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
3 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
Star Drive M/E 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-2359-2018 · 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-2358-2018 · 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-2352-2018 · Root cause: Device Design · Recall details · FDA record ↗
Star Drive M/E models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Star™ Drive M/E FC8002-00149Neurological stereotaxic Instrument2 recalls0 reports
- Star™ Drive M/E FC8002-00637Neurological stereotaxic Instrument2 recalls0 reports
- STar™ Drive M/E 70-ZD-ME-00215Neurological stereotaxic Instrument1 recall0 reports
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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