VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.

Reason: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

Code information: UDI-DI 00685447006121 Lot 35935598

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.