Medtronic, Inc. recalls Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crom…

Recall date

June 18, 2025

Source

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

Recall number

Z-2169-2025

FDA classification

Class II

Brand / firm

Medtronic, Inc.

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

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

What was recalled

Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;