Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Aurora EV-ICD and Clinical EV-ICD Recalled by Medtronic, Inc. Due to There is a potential for delayed time to...

Date: October 29, 2025
Company: Medtronic, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic, Inc. directly.

Affected Products

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

Quantity: 6591 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic, Inc.

Medtronic, Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report