FDA-Device2025-07-16Class II
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.
Boston Scientific Corporation
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Affected count
14,724
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2104-2025Don't want to check this manually?
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