Medtronic Neuromodulation: Medical Device Recall in 2014 - (Recall #: Z-2118-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 11, 2014

Date Posted: August 6, 2014

Recall Number: Z-2118-2014

Event ID: 68615

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.

Status: Terminated

Product Quantity: 300 EXPANDED 10/02/2014 130 devices

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated