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U.S. Department of Health and Human Services

Class 2 Device Recall Nexdrive Micropositioning Drive

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  Class 2 Device Recall Nexdrive Micropositioning Drive see related information
Date Initiated by Firm June 11, 2014
Date Posted July 25, 2014
Recall Status1 Terminated 3 on January 22, 2015
Recall Number Z-2118-2014
Recall Event ID 68615
510(K)Number K022100  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000.

For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures.
Code Information Lot numbers: 082605614, 082601414, 082602014, 082634313, 082630913, 082629713, 082629613, 082626913, 082623113, 082621413, and 082618213.   EXPANDED 10/02/2014 Lot Numbers: 082616214, 082616314, 082618314, and 082618414.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Technical Services
800-707-0933
Manufacturer Reason
for Recall		 Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Medtronic sent an Urgent Medical Device Recall letter dated June 2014 on June 11, 2014, to all affected customers. The letter described the problem and the product involved in the recall. The letter described the "Action Requested" which included to stop using and return the recalled device and to complete and return the Reply Form. Customers with questions were instructed to contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. EXPANDED 10/02/2014: Medtronic sent an Urgent Medical Device Recall letter beginning 10/02/2014. The letter explained that this letter is an update to the June 2014 action, to include 4 additional lot numbers. The letter explained the reason for recall identified all lots recalled and asked that devices stopped being used. A response form provided instructions on how to return product and the form was asked to be returned within 10 days. Questions should be directed to Medtronic Neuromodulation Technical Service at 1-800-707-0933, weekdays 7 am - 6 pm, Central time.
Quantity in Commerce 300 EXPANDED 10/02/2014 130 devices
Distribution Worldwide Distribution - USA including CA, CO, FL, IL, KS, KY, LA, MN, MT, NC, NE, OR, TX, VA, and UT, and Internationally to Canada, Spain, and United Kingdom.
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 = IMAGE-GUIDED NEUROLOGICS, INC.
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