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.
International English - Physician Communication, July 2022 – Zenex, Assurity, and Endurity Pacemaker Header
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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.
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