Medtronic Alerts Variation in Reflective Material on Passive Spheres May Impact Navigation Tracking

The sphere manufacturer has identified a variation in the reflective material used on a limited number of sterile passive sphere lots. The reflective material is the outer coating of the sphere that reflects infrared light from the optical tracking cameras, enabling detection and tracking of instruments during navigation procedures. Medtronic has determined that this variability may affect the ability of the navigation system to detect and track the spheres. Potential impacts may include instrument verification failures, intermittent or lost tracking, red status tracking or navigation accuracy.