A subset of Emblem S-ICDs was manufactured in September and has an incorrect date/timestamp which may cause an inaccurate display of battery capacity. The device's manufacturing date/timestamp is used by the programmer and latitude™ patient management system to calculate and display the battery capacity. The battery capacity value is intended to decrement in a linear manner over the device's implant life. For devices with an incorrect manufacturing date/timestamp, the initial battery capacity displayed after exiting storage mode is approximately 10%. This displayed battery capacity behavior does not affect the device's performance (i.e., ability to detect/treat arrythmias) or the actual battery longevity. Recall start date: October 3, 2022.
RecallTracker