VersaCross RF Wire (Boston Scientific) – Sterile Barrier Compromise (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
UDI-DI 00685447006121 Lot 35935598
Products Sold
UDI-DI 00685447006121 Lot 35935598
Boston Scientific Corporation is recalling VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product I due to Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic in. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On June 10, 2025, the firm began notifying consignees of the field action via Urgent Medical Device Removal letters. Customers are instructed to not use affected product. They should remove affected units from their inventory and segregate the units in a secure place until they can be returned to Boston Scientific.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026