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Device Lookup

For Zenex, Assurity, and Endurity Pacemakers Safety Notification

Product Advisories

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 (PDF 175 KB)

Visit our Product Advisories 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. 

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

Please note, this device lookup tool is specific to the 2022 advisory. To look up whether the device is subject to a prior advisory, please refer to the respective Product Advisories lookup tools listed above.

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