Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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.

FDA Recall Z-2104-2025 · Posted 2025-07-10

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeDXF
Date Initiated2025-06-10
Product Quantity14,724

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.

Firm Action

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.

Root Cause

Packaging change control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑