FDA Device recall Z-2118-2014
Medtronic Nexdrive Micropositioning Drive
- FDA Device
- Class II
- terminated
- Published 2014-08-06
On 2014-08-06 the FDA classified a Class II recall of Medtronic Nexdrive Micropositioning Drive by Medtronic Neuromodulation, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2118-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-11 |
| Published | 2014-08-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | CA, CO, FL, IL, KS, KY, LA, MN, MT, NC, NE, OR, TX, UT, VA |
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.
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.
Identifiers
| code_info | Lot numbers: 082605614, 082601414, 082602014, 082634313, 082630913, 082629713, 082629613, 082626913, 082623113, 082621…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2118-2014%22
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