Product Wiki · Recalls · Health Canada — Medical Devices

DLP Antegrade Aortic Root Cardioplegia Cannulae — recall 76947

Health Canada — Medical Devices · Canada · 2025-02-13 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
76947
Date of alert
2025-02-13
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: During the manufacturing process, unexpected loose plastic material in the male luer used in the aortic root cannula was identified. The potential harms when identified prior to use is procedure delay while another cannula is located. If this is not identified prior to use, and the clinician uses the cannula, the potential harm is stroke (reversible and irreversible). Recall Start Date: February 5, 2025
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dlp-antegrade-aortic-root-card

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