Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product…

Recall date

October 29, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0726-2026

FDA classification

Class II

Brand / firm

Medtronic, Inc.

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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