November 11, 2025 – In a subset of patients with Medtronic EV-ICD, a potential delay in high voltage (HV) therapy may occur due to a rare sequence of events involving the device’s dynamic sensing algorithm. This behavior applies only to non-committed shocks.
Authors
Molly Sachdev, MD, MPH; Christopher F. Liu, MD; Lisa Miller, MS; Sana M. Al-Khatib, MD, MHS; Mina K. Chung, MD; Amit J. Shanker, MD
Correspondence
[email protected]
Impacted Models
Aurora EV-ICD™ (DVEA3E4), Clinical EV-ICD (DVEX3E4)
Recall Issue Summary
In a subset of patients with Medtronic EV-ICD, a potential delay in high voltage (HV) therapy may occur due to a rare sequence of events involving the device’s dynamic sensing algorithm. This behavior applies only to non-committed shocks. This includes cardioversion (CV) therapies in the ventricular tachycardia (VT) and fast ventricular tachycardia (FVT) zones, and the first shock in the ventricular fibrillation (VF) zone. The technical details regarding this behavior are described in Medtronic’s letter sent to providers.
There have been zero reports of permanent harm or death due to this behavior. Thus far, six events (delay of 2-17 seconds) were observed among approximately 4,900 implanted devices worldwide (~0.12%). Five of the six events experienced this behavior during a controlled defibrillation threshold test.
A device update via CareLink™ SmartSync™ Device manager is available to eliminate this potential delay.
Manufacturer Recommendations
- 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 the update within the next 3-6 months.
HRS Recommendations
HRS strongly encourages its members worldwide to read the Medtronic Safety Notification. HRS agrees that prophylactic generator change is not recommended. We do recommend scheduling an in-clinic visit to complete the described software update that will prevent the event.
Reporting Contact
Adverse events should be reported to your local Boston Scientific representative or Technical Services and to regulatory authorities such as the FDA for our US based members.
FDA’s MedWatch
Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
For additional questions, contact your local Medtronic Representative or Medtronic Technical Services at 1-800-723-4636.
Topic
- Device Therapy
- Electrophysiology
Resource Type
- Safety Alerts
Manufacturer
- Medtronic
Device Type
- ICDs & CRT-Ds
FDA Class
- Class I
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