FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: 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.
- Recall number
- Z-2589-2021
- Recalling firm
- Atrium Medical Corporation
- 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.
- Status
- Terminated
- Initiated
- 2021-08-25
- Posted
- not on file
- Terminated
- 2024-04-10
- Reason
- The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
- Root cause
- Under Investigation by firm
- Action
- 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).
- Quantity
- 28 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K992960"]
- PMA numbers
- not on file
- Product code
- DSY
- Firm FEI
- 3011175548
- Firm city
- Merrimack
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28