Recall Z-2118-2014 ยท HAW Neurological Stereotaxic Instrument
Medtronic Neuromodulation
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.
| Date | Jul 25, 2014 (initiated Jun 11, 2014) |
| Status | Terminated |
| Reason | 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 | 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 up |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022100 | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 Image-Guided Neurologics, Inc., Sep 25, 2002 |