Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.

On August 25, 2021, the firm issued Urgent Medical Device - Removal letters to affected customers. Customers were instructed to do the following: - Please examine your inventory immediately to determine if you have any of the Atrium Advanta VXT Vascular Grafts with Part Number/REF Number 22059. - If you have affected product with Part Number/REF Number 22059, please remove the affected products from areas of use and return the product(s) to Getinge following the instructions in the letter. - Should you have affected product you are eligible for either a replacement or credit. - Please forward this information to all current and potential Atrium Advanta VXT Vascular Graft users within your hospital / facility. - If you are a distributor who has shipped any affected products to customers, please forward the recall notification to their attention for appropriate action. - Please contact Getinge Customer Service at (603) 880 1433 to request a return authorization (RMA) and shipping instructions to return any affected product. - Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided by Getinge Customer Service, arrange for pickup with the designated delivery service provider. If you have any questions, please contact your Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880 1433, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).