Home / Recalls / Medical Devices
Medtronic, Inc. recalls Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt
Recalled July 30, 2025 · FDA recall Z-2168-2025 · Medtronic
Hazard
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. · FDA Class II
Units
22091 total devices
Sold at
Worldwide - US Nationwide distribution.
Description
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.
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;
Manufacturer(s)
Medtronic, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →