Advanta V12
Brand(s)
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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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
Get notified
Receive notifications for new and updated recalls and alerts by category.