Advanta V12 recall in Canada: Medical device quality issue
In plain language
This recall involves the Advanta V12 medical device sold in Canada. It's being recalled due to an increased rate of customer complaints related to the separation of the balloon or catheter hub from the delivery catheter. Contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
Advanta V12
Model: 85320, 85321, 85322, 85323, 85324, 85325, 85326, 85327, 85328, 85329, 85331, 85332, 85333, 85334, 85335, 85336, 85337, 85338, 85340, 85343, 85344, 85345, 85350, 85351, 85352, 85353, 85354, 85355, 85360, 85361, 85364, 85365, 85371, 85372, 85379, 85388, 85389, 85390, 85391, 85397, 85398
Lot: All lots
Why this matters
Medical device quality issue
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 85320, 85321, 85322, 85323, 85324, 85325, 85326, 85327, 85328, 85329, 85331, 85332, 85333, 85334, 85335, 85336, 85337, 85338, 85340, 85343, 85344, 85345, 85350, 85351, 85352, 85353, 85354, 85355, 85360, 85361, 85364, 85365, 85371, 85372, 85379, 85388, 85389, 85390, 85391, 85397, 85398
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Medical device quality issue
What should consumers do?
Contact the manufacturer if you require additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Medical device quality issue
When was this product recalled?
This product was recalled on March 7, 2022.
Is the ATRIUM MEDICAL CORPORATION brand affected by this recall?
Yes, ATRIUM MEDICAL CORPORATION products are affected by this recall. This recall involves the Advanta V12 medical device sold in Canada. It's being recalled due to an increased rate of customer complaints related to the separation of the balloon or catheter hub from the delivery catheter. Contact the manufacturer for more information.