Boston Scientific Corporation recalls VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device app…

Recall date

June 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2104-2025

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.