Quick summary
Quick summary: Advanta V12. Date: 2023-10-11.
Public recall detail
Advanta V12
2023-10-11
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Advanta V12. Date: 2023-10-11.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandATRIUM MEDICAL CORPORATION
ProductAdvanta V12
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74409
Affected products
ProductAdvanta V12
Lot464909 464910
Model85361
Serial number464909 464910
DescriptionAdvanta V12
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
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesAtrium Medical Corporation 40 Continental Blvd., Merrimack, New Hampshire, United States, 03054
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74409
Background{}
CompaniesAtrium Medical Corporation 40 Continental Blvd., Merrimack, New Hampshire, United States, 03054
AudiencesHealthcare
Source updated2023-10-11
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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