Recall Z-2168-2025— Medtronic, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic, Inc., initiated 2025-06-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic CareLink SmartSync Patient Connector, Model Number 24967 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;. Reason: 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..
- Recalling firm
- Medtronic, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-18
- Firm location
- Mounds View, MN, United States
Product description
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 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;
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.