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Health Canada Medical devices

Amplatzer Torqvue Delivery System

Issued March 26, 2025
Issue
Abbott is voluntarily recalling certain 4F Amplatzer™ Torqvue™ LP Delivery System (TVLP) and 4F Amplatzer™ Torqvue™ LP Catheter (TVLPC) devices, which were impacted by a manufacturing anomaly. Any impacted lots which have not yet been consumed should be returned to Abbott. All other lots are not affected and can continue to be used. To date, there have been no reports of patient harm associated with devices from the impacted lots. Recall Start Date: March 17, 2025
Hazard description
Performance
Product
Product name
Amplatzer Torqvue Delivery System
Reference
ID
RA-77187