Safety Notification Update FOR A SUBSET OF ASSURITY™ AND ENDURITY™ PACEMAKERS - LEADconnection

Safety Notification Update FOR A SUBSET OF ASSURITY™ AND ENDURITY™ PACEMAKERS

Posted on November 9th, 2022
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Original communication March 2021, Update October 2021

A subset of Abbott AssurityTM and EndurityTM pacemakers may be impacted by intermittent incomplete mixing of epoxy in the manufacturing process. This issue may potentially allow moisture ingress into the pulse generator header, introducing a risk of interrupting device functionality. The safety notification communication is below and posted on the Abbott website.