BEUDAMED
    FDA Recall Open, Classified

    Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4

    Recall: Z-0726-2026 · Initiated October 29, 2025

    Recall

    Recall Number
    Z-0726-2026
    Event Number
    97910
    Firm
    Medtronic, Inc.
    FEI Number
    2182208
    Product Code
    LWS
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    October 29, 2025
    Posted
    November 28, 2025
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4

    Reason

    There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

    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 [email protected] 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.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    6591 units