Abbott has identified that a subset of Assurity and/or Endurity pacemaker(s) are impacted by a manufacturing issue. As background, the issue in this recall is connected to a manufacturing laser roughening process, unique to a single assembly site production line, which may not have properly prepared the device's metal housing potentially leading to an abnormal bond adhesion. This in turn may allow moisture ingress into the pulse generator header. This specific manufacturing process is no longer in use. While Abbott continues to investigate this issue further, Abbott has initiated a recall of the impacted devices, which will be executed in two phases: phase I initiated now and phase II initiated on July 28,2022. Endurity pacemaker(s) PM2172 not distributed in Canada. Recall start date: July 20, 2022
RecallTracker