—#189079

Product

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.

FDA product code: DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K992960
Affected lot / code info: Lot 458755 Serial numbers 458755001 458755007 458755013 458755019 458755025 458755002 458755008 458755014 458755020 458755026 458755003 458755009 458755015 458755021 458755027 458755004 458755010 458755016 458755022 458755028 458755005 458755011 458755017 458755023 458755029 458755006 458755012 458755018 458755024 458755030

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: Atrium Medical Corporation
Address: 40 Continental Blvd, Merrimack, New Hampshire 03054-4332

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.

Timeline

Recall initiated: 2021-08-25
Terminated: 2024-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189079. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.