—#214627

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;

FDA product code: NVZ — Pulse Generator, Permanent, Implantable
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P890003
Affected lot / code info: 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.

Why it was 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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Medtronic, Inc.
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: Worldwide - US Nationwide distribution.

Timeline

Recall initiated: 2025-06-18
Posted by FDA: 2025-07-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214627. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.