Nexdrive Micropositioning Drive Models ML-1000 and ML-2000 (2014-06-19)

Starting date:

June 19, 2014

Posting date:

July 10, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-40403

• 
  Reason
• 
  Affected products

Recalled Products

Nexdrive Micropositioning Drive Models ML-1000 and ML-2000

Reason

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.

Affected products