Reported Aug 6, 2014 · Terminated
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- 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.
- Lot codes and dates
- Lot numbers
082605614082601414082602014082634313082630913082629713082629613082626913082623113082621413and 082618213
- EXPANDED 10/02/2014 Lot Numbers
082616214082616314082618314and 082618414
- Lot numbers
- Amount recalled
- 300 EXPANDED 10/02/2014 130 devices
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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