Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Cro

FDA device recall Z-2168-2025 · posted 2025-07-23 · Open, Classified

Recall details

Recalling firm

Medtronic, Inc.

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.

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.

Root cause

Software design

Status

Open, Classified

Product code

NVZ

Quantity affected

22091 total devices

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2025-06-18

Date posted

2025-07-23

Location

Mounds View, MN