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Health Canada Medical devices

Heartstring III Proximal Seal System

Issued August 28, 2025
Issue
Three primary failure modes have been identified. Failure of the heartstring seal to load. Failure of the heartstring seal to deploy into the aortotomy Failure of the deployed heartstring seal to provide adequate hemostasis Recall start date: August 14, 2025
Hazard description
Performance
Product
Product name
Heartstring III Proximal Seal System
Reference
ID
RA-77998