Product Wiki · Recalls · Health Canada — Medical Devices

ACCOLADE™ MRI Pacemaker — recall 76188

Health Canada — Medical Devices · Canada · 2024-09-24 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
76188
Date of alert
2024-09-24
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: Boston Scientific is retrieving specific model l331 ACCOLADE™ pacemakers due to inadvertent re-use/duplication of certain model/serial number combinations. This duplication occurred during the manufacturing of devices built over the past month. There are no performance concerns with these pacemakers, and they have passed all manufacturing tests. Additionally, there have been no reported adverse events or patient harms related to their use. Recall start date: September 12, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/accoladetm-mri-pacemaker

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