Official recall record
Assurity and Endurity Pacemakers
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-02-27
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Abbott is informing clinicians of the potential for a device malfunction affecting a subset of Assurity™ and Endurity™ 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. Recall start date: February 18, 2025
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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