microTargeting" STar" Drive System — Class II medical device recall Z-2357-2018
Terminated recall by FHC, Inc., reported 2018-07-11, distributed in AL, AR, AZ, CA, CO, DC, DE, FL…. The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened
| Recall number | Z-2357-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | FHC, Inc., Bowdoin, ME, United States |
| Recall initiated | 2018-05-10 |
| Classified | 2018-07-05 |
| Reported by FDA | 2018-07-11 |
| Terminated | 2019-04-30 |
| Distributed | AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AR, AU, CA, CH, DE, DK, EC, FR, GB, IT, JP, NO, RO, SA, TW, ZA |
| Quantity | 2,952 total |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00873263001486, 00873263006351 |
Product
microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.