Z-2354-2018Class II

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

Name: Z-2354-2018 microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
Creator: FHC, Inc.
Published: 2018-05-10
License: https://open.fda.gov/license/

FHC, Inc. / initiated 2018-05-10 / Terminated / root cause: design

FDA source

FHC, Inc. began a recall of microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB on 2018-05-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2354-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-10
Posted: 2018-07-05
Terminated: 2019-04-30
Recalling firm: FHC, Inc.
Product: microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Recall notification letters were sent to customers on 5/10/18. The letters included the following instructions: FHC, Inc. Field Representatives will review your inventory and replace effected Depth Stop Adapters you have on hand with an improved design. In the interim, we advise that you do not over-tighten the Depth Stop Adapter screw. If low impedances or a short circuit is found, physicians should replace the lead prior to use and report the issue to FHC, Inc. or your local field rep.
Quantity in commerce: 2952 total
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.
Product codes and lots: UDI: 00873263002643

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2354-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2345-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2346-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2347-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2348-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2349-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2350-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2351-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2352-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2353-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2354-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2355-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2356-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2357-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2358-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2359-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05

Product code HAW

K092562Class IIMicrotargeting Star Drive System, ComponentsFHC, Inc. / cleared 2009-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)