Advanta V12
Brand(s)
Last updated
Summary
Product
Advanta V12
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Advanta V12 |
464909 |
85361 |
Issue
Atrium/Getinge is initiating a voluntary medical device recall/removal for the Advanta V12 covered stent system due to an identified manufacturing deficiency that may cause a loss of balloon pressure or inability to hold balloon pressure during Advanta V12 balloon-expandable covered stent deployment.
Recall start date: September 25, 2023
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
Healthcare
Recall class
Type II
Identification number
RA-74409
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