Recall Z-2169-2025

Medtronic, Inc. · initiated June 18, 2025

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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;

Codes / lots: 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.

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.

FDA-determined cause: Software design

Action taken

An URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letter dated 6/18/25 was sent to customers. Customer Actions: "Update SmartSync (to version 4.2.3 or higher). Refer to release notes provided by your local Medtronicrepresentative for update instructions. If needed, Medtronic representatives are available to work with you toinstall or update the SmartSync application(s) on your tablet. See Appendix for instructions on how to verify thesoftware update is complete. "Sign and return the enclosed confirmation form and share this notice with those who need to be aware withinyour organization or with any organization where SmartSync may be in use. Questions regarding this informationshould be directed to the local Medtronic Representative or Medtronic Programmer Technical Services at 800-638-1991, Option 1.

Details

Recall number: Z-2169-2025
Initiated: June 18, 2025
Posted by FDA: July 23, 2025
Product code: NVZ – Pulse Generator, Permanent, Implantable
Quantity: 22091 total devices
Distribution: Worldwide - US Nationwide distribution.
Recalling firm: Medtronic, Inc., Mounds View, MN

Official FDA recall record

Other products in the same recall event

Recall	Product	Initiated
Z-2168-2025 Class II	Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following…In prior SmartSync application versions, the Abort button stopped the test that was selected. During an…	06/18/2025Open, Classified