—#128310

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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K022100
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-06-11
Posted by FDA: 2014-07-25
Terminated: 2015-01-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128310. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.