VersaCross RF Wire recall: Sterility Concern
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in…
Why was VersaCross RF Wire 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00685447006121 Lot 35935598
- Product
- VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 14,724
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
- Recall date
- July 16, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)