Class 1 Device Recall StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1

• Date Initiated by Firm: March 26, 2024
• Date Posted: May 09, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1776-2024
• Recall Event ID: 94411
• 510(K)Number: K162309
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or; percutaneous neurosurgical procedures.
• Code Information: UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341/ Software Versions: 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1.
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc.; 200 Medtronic Drive; Lafayette CO 80026
• For Additional Information Contact: Rita Greenberg; 720-890-3200
• Manufacturer Reason for Recall: Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
• FDA Determined Cause: Software design
• Action: On April 10, 2024, Medtronic Navigations, Inc. issued an Urgent: Medical Device Correction to affected consignees via UPS. In addition to informing consignees about the issue, Medtronic asked consignees to take the following actions: 1. Please review this information with all physician users. If you have any questions related to this issue, please contact Medtronic Technical Services for help at 1-888-826-5603 or email at rs.navtechsupport@medtronic.com. 2. Please confirm via the enclosed confirmation form that this notification has been communicated within your facility with all physician users. Send the completed Customer Confirmation Form to Medtronic via email at neuro.quality@medtronic.com. a. Medtronic will work expeditiously with your facility to coordinate a software update at no charge to resolve this anomaly. 3. Pass this notice on to those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. 4. Adverse reactions or quality problems experienced with this product should be reported to FDA and Medtronic. Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail). Call FDA at (800) FDA-1088. Call Medtronic Technical Services at 1-888-826-5603.
• Quantity in Commerce: 3286 applications.
• Distribution: Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Republic Of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, Nicaragua, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
• 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 and Original Applicant = MEDTRONIC NAVIGATION, INC.