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Health Canada Medical devices

Advanta V12

Issued March 7, 2022
Issue
Atrium/Getinge is initiating a voluntary medical device field correction 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: Mar 3. 2022
Hazard description
Quality
Product
Product name
Advanta V12
Reference
ID
RA-63969