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U.S. Department of Health and Human Services

Class 2 Device Recall microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66CNDB

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  Class 2 Device Recall microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66CNDB see related information
Date Initiated by Firm May 10, 2018
Create Date July 05, 2018
Recall Status1 Terminated 3 on April 30, 2019
Recall Number Z-2353-2018
Recall Event ID 80148
510(K)Number K011992  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product microTargeting" Lead Adapter
for microTargeting" Drive, Product Number 66-CN-DB
Code Information UDI: 00873263004531
Recalling Firm/
Manufacturer		 FHC, Inc.
1201 Main St
Bowdoin ME 04287-7302
For Additional Information Contact Kelly Moeykens
207-666-5425
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = FHC, INC.
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