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Health Canada Medical devices

Advanta V12 Covered Stent System

Issued July 11, 2023
Issue
Atrium/Getinge is initiating a voluntary medical device field correction/notification for the Advanta v12 Covered Stent System due to an increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal. Recall Start Date: June 27, 2023
Hazard description
Performance
Product
Product name
Advanta V12 Covered Stent System
Reference
ID
RA-73917