FDAFDA · Food and drugs·Recall number Z-2118-2014
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.
Published August 6, 2014 · Recall initiated: June 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Neuromodulation
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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