Z-2118-2014Class II

Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the...

Name: Z-2118-2014 Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the...
Creator: Medtronic Neuromodulation
Published: 2014-06-11
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2014-06-11 / Terminated / root cause: manufacturing process

FDA source

Medtronic Neuromodulation began a recall of Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise... on 2014-06-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2118-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-11
Posted: 2014-07-25
Terminated: 2015-01-22
Recalling firm: Medtronic Neuromodulation
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.
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2118-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2118-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-25

Product code HAW

K022100Class IINavigus Manual Disposable Microdrive with Digital Display, Models Mi-1000 & Mi-1010Image-Guided Neurologics, Inc. / cleared 2002-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)