Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic CareLink SmartSync Device Manager Recalled by Medtronic, Inc. Due to In prior SmartSync application versions, the Abort button...
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
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;
Quantity: 22091 total devices
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic, Inc.
Medtronic, Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report