# FDA recall Z-2350-2018

> **FHC, Inc.** · Class II · device recall initiated 2018-05-10.

## 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.

## Distribution

The devices were distributed to the following US states: 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, and WY.    The devices were distributed to the following foreign countries:  Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland,  Saudi Arabia, Taiwan.

## Key facts

- **Recall number:** Z-2350-2018
- **Recalling firm:** FHC, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-10
- **Report date:** 2018-07-11
- **Termination date:** 2019-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bowdoin, ME, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2350-2018

## Citation

> AI Analytics. FDA recall Z-2350-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2350-2018. Source: US FDA. Licensed CC0.

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