Medtronic Nexdrive Micropositioning Drive. Models Ml-1000… recallZ-2118-2014 · Medtronic Neuromodulation · initiated Jun 11, 2014
Class II Terminated All recalls posted in July 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2118-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 11, 2014
- Posted by the FDA
- Jul 25, 2014
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 300 EXPANDED 10/02/2014 130 devices
- Product code
- HAW
- FDA submissions
- K022100
- 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.
Product description
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 (models, lots, serial numbers)
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.
Other devices under the same FDA submission
4 devices cleared under K022100 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NEXDRIVE™ MI-2000Medtronic, Inc. · Neurological stereotaxic Instrument1 recall1 report
- NEXDRIVE™ MI-1000Medtronic, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- Nexdrive™ MI-1000Medtronic, Inc. · Neurological stereotaxic Instrument3 reports
- Nexdrive™ MI-2000Medtronic, Inc. · Neurological stereotaxic Instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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