Beginning July 2022, Abbott informed customers of an issue which may affect a subset Zenex™, Assurity™, and Endurity™ pacemakers that include models: PM2152, PM2162, PM2172, PM2272, PM2282. Abbott has identified an issue connected to a manufacturing laser roughening process, unique to a single assembly site, which may have resulted in inadequate device-to-header adhesion, and which in turn may allow moisture ingress into the pulse generator header. This specific manufacturing process is no longer in use. Affected devices vary based on commercial availability in each region.
This tool enables healthcare professionals to confirm if a specific device is subject to this safety notification.
Please follow the steps below to determine if a Zenex, Assurity, or Endurity pacemaker is subject to this global safety notification.
If you are a patient and have questions about your device, please contact your treating physician.
Enter the four digit model number without the prefix (PM). Next, enter the entire serial number.
Please note that a separate device lookup tool is linked above for the March/October 2021 Assurity and Endurity pacemaker header advisory.
You are about to enter an Abbott country- or region-specific website.
Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions
Do you wish to continue and enter this website?