FHC, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2355-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

microTargeting" Drive System Distributed by Medtronic, Product Number FC1006

Product Classification:

Class II

Date Initiated: May 10, 2018

Date Posted: July 11, 2018

Recall Number: Z-2355-2018

Event ID: 80148

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.

Status: Terminated

Product Quantity: 2952 total

Code Information:

UDI: 00873263001479

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated