Medical Device Recall: 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 · June 10, 2025
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
States Affected
NATIONWIDE
Quantity Affected
14,724
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2104-2025
Status: ongoing
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