Safety Enforcement Notice

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;

Issued for products by Medtronic, Inc.

Recall Event Details

Primary ID / Event Code: Z-2168-2025
Classification Code: 1. Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5; 2. Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5; 3. Software Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2; 4. Software Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6; 5. Software Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6; 6. Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5; 7. Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2; 8. Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2; 9. Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2; 10. Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2; 11. Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.
Manufacturer: Medtronic, Inc.
Reported Date: August 9, 2026