FDA recall Z-2589-2021

Atrium Medical Corporation · Class II · device

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 for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-08-25
Report date
2021-10-06
Termination date
2024-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2589-2021