VersaCross RF Wire — Class II medical device recall Z-2104-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-07-16, distributed nationwide. Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Iss
| Recall number | Z-2104-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2025-06-10 |
| Classified | 2025-07-10 |
| Reported by FDA | 2025-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK, JP |
| Quantity | 14,724 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00685447006121 |
| Lot numbers | 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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2104-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.