Recall Z-2589-2021— Atrium Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Atrium Medical Corporation, initiated 2021-08-25, terminated 2024-04-10. It names one FDA 510(k) clearance: K992960. 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.. Reason: The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling..
- Recalling firm
- Atrium Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-25
- Terminated
- 2024-04-10
- Firm location
- Merrimack, NH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.