microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately g...
FDA Device Recall #Z-0312-2025 — Class I — October 4, 2024
Recall Summary
| Recall Number | Z-0312-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | October 4, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | FHC, Inc. |
| Location | Bowdoin, ME |
| Product Type | Devices |
| Quantity | 8 packs of 5ea (40 total) |
Product Description
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
Reason for Recall
A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.
Distribution Pattern
Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
Lot / Code Information
Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
Other Recalls from FHC, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2540-2020 | Class II | FHC Guideline 4000 5.0 GL5 Main Processing Uni... | Jun 17, 2020 |
| Z-2349-2018 | Class II | microTargeting" STar" Drive System (Manual), P... | May 10, 2018 |
| Z-2351-2018 | Class II | microTargeting" STar" Drive System (Manual), P... | May 10, 2018 |
| Z-2345-2018 | Class II | microTargeting" Drive System, Product Number MT-DS | May 10, 2018 |
| Z-2347-2018 | Class II | microTargeting" Drive System, Product Number 66... | May 10, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.