CareLink SmartSync™ Applications

Issue

This recall pertains to a device electrical reset message being displayed inappropriately (i.e., when a true device electrical reset did not occur). There are two issues when the device electrical reset message is displayed inappropriately: Issue #1: The user is informed there was a device electrical reset when there was not. This can cause confusion and might lead the user to believe the device is no longer functioning properly. Issue #2: One of the messages that can be displayed inappropriately recommends device explant ("serious device error: device should be explanted"). While the message may be factually correct for the type of electrical reset it is designed to indicate, if displayed inappropriately it increases the risk of explant and patient harm. Recall start date: June 18, 2025