Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.

On 11/09/21, recall notices were distributed to healthcare professionals. The firm requested the following actions: 1) Identify, segregate, and quarantine affected products within your inventory. 2) Complete and return the Customer Confirmation Form even if you do not have inventory. The Customer Confirmation Form must be returned to initiate the Return Good Authorization (RGA) process. The RGA will be provided to you upon Medtronic receipt and processing of the Customer Confirmation Form. 3) Upon customer receipt of the RGA, return the affected product as instructed in the RGA. 4) This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 5) Maintain a copy of this notice in your records. Customers with questions are encouraged to call: 1-888-826-5603. The recalling firm is working with its suppliers to make inventory available as soon as possible at which point a replacement device will be provided at no additional cost. Until replacement product is available, navigated alternatives can be used.