Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VersaCross RF Wire (VXW). Indicated for creation of an atrial Recalled by Boston Scientific Corporation Due to Potential for hole in the Tyvek layer of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected 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.
Quantity: 14,724
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report