Product Wiki · Recalls · Health Canada — Medical Devices

Assurity & Endurity Pulse Generarators (Pacemaker) (2021-03-15) — recall 62302

Health Canada — Medical Devices · Canada · 2021-04-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62302
Date of alert
2021-04-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Electrical malfunction has been detected at a low rate amongst a subset of Assurity and Endurity Pacemakers manufactured on specific manufacturing equipment between 2015 and 2018. Complaint investigation identified the issue and determined that the electrical issues were due to moisture ingress at the device header caused by incomplete mixing of epoxy during manufacturing.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/assurity-endurity-pulse-genera

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