Z-2104-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 16, 2025
- Initiation Date
- June 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,724
Product Description
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 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 Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Code Information
UDI-DI 00685447006121 Lot 35935598