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

FDA device recall Z-0726-2026 · posted 2025-11-28 · Open, Classified

Recall details

Recalling firm

Medtronic, Inc.

Reason for recall

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

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

LWS

Quantity affected

6591 units

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2025-10-29

Date posted

2025-11-28

Location

Mounds View, MN