Abbott is informing clinicians of the potential for a device malfunction affecting a subset of Assurity™ and Endurity™ pacemakers. This issue may result in incomplete mixing of epoxy during manufacturing and, with time, may permit moisture ingress into the pulse generator header, introducing a risk of interrupting device functionality. Affected devices were manufactured between August 2019 and June 2020. Recall start date: February 18, 2025
RecallTracker