Z-2589-2021Class II

Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 -

Name: Z-2589-2021 Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 -
Creator: Atrium Medical Corporation
Published: 2021-08-25
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2021-08-25 / Terminated / root cause: labeling and UDI

FDA source

Atrium Medical Corporation began a recall of Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass... on 2021-08-25. FDA classified it as Class II and gives the reason as "The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2589-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-25
Posted: 2021-09-29
Terminated: 2024-04-10
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.
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
Root cause tag: labeling and UDI
FDA 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 in commerce: 28 units
Distribution: Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2589-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2589-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-29

Product code DSY

K992960Class IIAdvanta Graft (>6Mm)Atrium Medical Corp. / cleared 1999-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)