Beginning February 2025, Abbott informed customers of the potential for a device malfunction affecting a subset of Assurity™, Endurity™, Zenex™*, and Zenus™* pacemakers. This issue may result in incomplete mixing of epoxy during manufacturing and, with time, may permit moisture ingress into the pulse generator header, introducing a risk of interrupting device functionality. Affected devices were manufactured between August 2019 and June 2020. The specific manufacturing equipment associated with this issue is no longer in use. No affected devices remain available for implant.
* Japan only.
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, Zenus, Assurity, or Endurity pacemaker is subject to this 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, this device lookup tool is specific to the February 2025 advisory. To look up whether the device is subject to a prior advisory, please refer to the respective Product Advisories lookup tools listed above.
MAT-2501749 v1.0
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MAT-2305078 v1.0