microTargeting" STar" Drive System — Class II medical device recall Z-2350-2018
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-2350-2018 |
|---|---|
| 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 | 00873263004432 |
Product
microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2350-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.