Class II

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

Medtronic, Inc. · October 29, 2025

Reason for Recall

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

Distribution

Worldwide - US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

6591 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0726-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.