Health product recall

Advanta V12

Last updated

Summary

Product
Advanta V12
Issue
Medical devices - Quality issue
What to do

Contact the manufacturer if you require additional information.
 

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Advanta V12

All lots.

85326, 85329, 85334, 85338, 85353, 85388, 85389, 85398, 85321, 85327, 85333, 85343, 85344, 85371, 85390, 85328, 85332, 85340, 85352, 85391, 85323, 85325, 85336, 85337, 85354, 85364, 85324, 85335, 85351, 85361, 85365, 85372, 85322, 85331, 85345, 85350, 85379, 85397, 85320, 85355, 85360

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

Additional information

Details
Original published date: 2022-03-09
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

Atrium Medical Corporation

40 Continental Blvd., Merrimack, New Hampshire

United States, 03054

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63969