Recall Z-0726-2026 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic, Inc.
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
| Date | Nov 28, 2025 (initiated Oct 29, 2025) |
| Status | Open, Classified |
| Reason | There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. |
| Root 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 mont |
| Quantity | 6591 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.