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.
Reported: July 16, 2025 Initiated: June 10, 2025 #Z-2104-2025
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 14,724
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product 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.. Recalled by Boston Scientific Corporation. Units affected: 14,724.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 16, 2025. Severity: Moderate. Recall number: Z-2104-2025.
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