Medtronic, Inc.: 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;

Recall number

Z-2169-2025

Recalling firm

Medtronic, Inc.

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;

Status

Open, Classified

Initiated

2025-06-18

Posted

2025-07-23

Terminated

not on file

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.

Root cause

Software design

Action

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.

Quantity

22091 total devices

Distribution

Worldwide - US Nationwide distribution.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

["P890003"]

Product code

NVZ

Firm FEI

2182208

Firm city

Mounds View

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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