Advanta V12
Brand(s)
Summary
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
Atrium Medical Corporation
40 Continental Blvd., Merrimack, New Hampshire
United States, 03054
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