FDA Device recall Z-2354-2018
microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
- FDA Device
- Class II
- terminated
- Published 2018-07-11
On 2018-07-11 the FDA classified a Class II recall of microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB by Fhc, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2354-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-10 |
| Published | 2018-07-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fhc |
| Distribution | 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 |
Product
microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
Reason
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.
Identifiers
| code_info | UDI: 00873263002643 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2354-2018%22
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