Class 2 Device Recall Aurora EVICD

• Date Initiated by Firm: October 29, 2025
• Date Posted: November 28, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0726-2026
• Recall Event ID: 97910
• PMA Number: P220012
• Product Classification: Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
• Product: Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
• Code Information: UDI-DI: 00763000368470, 00763000368463, 00763000217907, 00763000217891, 00763000288068, 00763000744694; Serial Numbers: EVS600036S EVS600038S EVS600034S EVS600044S EVS600033S EVS600048S EVS600049S EVS600139S EVS600039S EVS600040S EVS600056S EVS600140S EVS600075S EVS600149S EVS600060S EVS600157S EVS600032S EVS600154S EVS600161S EVS600045S EVS600050S EVS600150S EVS600061S EVS600064S EVS600065S EVS600178S EVS600201S EVS600058S EVS600180S EVS600168S EVS600156S EVS600057S EVS600212S EVS600164S EVS600155S EVS600167S EVS600134S EVS600209S EVS600177S EVS600170S EVS600055S EVS600220S EVS600236S EVS600141S EVS600166S EVS600254S EVS600211S EVS600234S EVS600142S EVS600357S EVS600353S EVS600210S EVS600354S EVS600218S EVS600364S EVS600348S EVS600374S EVS600369S EVS600384S EVS600343S EVS600207S EVS600371S EVS600389S EVS600053S EVS600135S EVS600367S EVS600206S EVS600349S EVS600344S EVS600408S EVS600365S EVS600407S EVS600052S EVS600203S EVS600350S EVS600411S EVS600412S EVS600051S 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• Recalling Firm/ Manufacturer: Medtronic, Inc.; 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Technical Services; 800-638-1991
• Manufacturer Reason for Recall: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
• FDA Determined Cause: Software design
• Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated October 2025 was sent to customers. PATIENT MANAGEMENT RECOMMENDATIONS FOR PREVIOUSLY DISTRIBUTED DEVICES: Medtronic acknowledges that each patient requires unique clinical considerations. Based on internal investigation and consultation with our Independent Physician Quality Panel, Medtronic provides the following guidance: "Prophylactic device replacement is NOT recommended. "Schedule an in-clinic SmartSync interrogation to receive the software update, with the intent for all patients to receive theupdate within the next 3-6 months. For patients remotely followed via CareLink, your Medtronic representative can provide a report to assist with identifying patients that require this in-person update. You may contact your local representative to obtain an updated copy of the report at any time. CUSTOMER ACTIONS: "Ensure your SmartSync application is updated to include the Aurora EV-ICD Application. Contact your Medtronic representative if assistance is needed. "Please complete the enclosed Confirmation Form, following review of this letter, and email toRS.FCACRM@medtronic.com to confirm receipt of this notification. "Please forward this notice to everyone within your organization who needs to be aware and to locations where thesedevices could be followed if they are outside of your organization. If you have questions regarding this communication, please contact your Medtronic Representative.
• Quantity in Commerce: 6591 units
• Distribution: Worldwide - US Nationwide distribution.
• 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.

• PMA Database: PMAs with Product Code = LWS