Medtronic has identified, through internal testing, that the weld where the tracker connects to the instrument tube may be subject to separation failure. While separation of the stealth autoguide tracker at the welded joint has not been reported by customers, Medtronic's testing identified the potential for this to occur and render the device unusable. If the weld separation is not identified prior to use, the issue has the potential to cause navigational inaccuracy. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury, including the potential for a life-threatening injury (hemorrhage, unintended tissue damage, permanent neurological injury) which could lead to death. Recall start date: Nov 12, 2021
RecallTracker