Nexdrive Micropositioning Drive Models ML-1000 and ML-2000… — recall 52012
Health Canada — Medical Devices · Canada · 2014-07-10 · Type II
As described by Health Canada — Medical Devices: Nexdrive Micropositioning Drive Models ML-1000 and ML-2000 (2014-06-19)
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Archived by the issuing authority — kept for reference
Reported risk: Medtronic is initiating a voluntary recall for the Nexdrive micro-positioning drive (Model ML-1000 and ML-2000) due to the 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. Medtronic received one (1) report of a misaligned z-stage scale discovered during a deep brain stimulation (DBS) surgical procedure that noted the microelectrode was 5 mm short of the target depth. This resulted in multiple microelectrode insertions and a prolonged duration for the surgical procedure.
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