Class 2 Device Recall Stealth Autoguide Tracker, Model: 28248

• Date Initiated by Firm: November 09, 2021
• Create Date: December 22, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0417-2022
• Recall Event ID: 89074
• 510(K)Number: K191597
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.
• Code Information: All lot numbers
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc.; 826 Coal Creek Cir; Louisville CO 80027-9710
• For Additional Information Contact: Kyra Nead; 720-890-3200
• Manufacturer Reason for Recall: A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury. Per 11/24/21 firm email: The Bundle Autoguide Reg Kit does not have a model number. The Bundle Autoguide Reg Kit is internal terminology and not visible to the customer and are used as sales and shipping configuration only. When this sales bundle is chosen by an internal Medtronic Sales Representative the devices included in the bundle are individually packaged and labeled and sent to the customer in a single shipment. The devices included in the bundle are ordered, packed, and shipped as individual medical devices with unique model numbers, which is the reason that the Autoguide Tracker (28248) and the Stealth Autoguide Basic Instrument Kit (9736188) are the only part numbers subject to this FCA.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 98
• Distribution: US: FL, NE, CA, MN, TX, OH, IL, AZ, KS, KY, OR, OK, WA, NV, MO, IN, MI, UT, MS, VA, SC. OUS: Canada, Sweden, Italy, France, Germany, Spain, Czech Republic, United Kingdom, India, Nepal, Japan, Turkey, China
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HAW