Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

microTargeting" Lead Adapter for STar" Drive Recalled by FHC, Inc. Due to The FHC Depth Stop Adapter may cause damage...

Date: May 10, 2018
Company: FHC, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact FHC, Inc. directly.

Affected Products

microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB

Quantity: 2952 total

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 46 states: AL, AZ, AR, CA, CO, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC

Affected (46 states)Not affected

About FHC, Inc.

FHC, Inc. has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report