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CARDIOVASCULAR
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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 

Visit our Product Advisory page for translated, country letters.

This tool enables healthcare professionals to confirm if a specific device is subject to this safety notification.

DEVICE LOOKUP INSTRUCTIONS 

Please follow the steps below to determine if a Zenex, Assurity, or Endurity pacemaker is subject to this global safety notification.

  1. Enter the device model and serial number below; both are required.
  2. If the device is subject to this notification, review the patient management recommendations in the safety notification.
  3. If the device is not subject to this notification, no further action related to this notification is needed.

If you are a patient and have questions about your device, please contact your treating physician.

CHECK A DEVICE 

Enter the four digit model number without the prefix (PM). Next, enter the entire serial number.  

 

 

MAT-2208885 v1.0

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.