Boston Scientific recalls VersaCross RF Wire (VXW0002) due to potential hole in sterile pouch risking infection. Affected units sold only in Japan. No remedy stated in recall notice.
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.
Boston Scientific is recalling VersaCross RF Wire (VXW0002) because it could have holes in the sterile packaging that might lead to infections. This device is only sold in Japan and is used for creating heart defects during procedures.
The sterile pouch that protects the device could develop small holes, which might allow bacteria to enter. This could cause serious infections like sepsis if the device is used without proper sterility. These holes might not be easily detected during medical procedures due to their small size.
Patients in Japan who received the VersaCross RF Wire (VXW0002) device for heart procedures are most at risk. The recall applies to this specific model sold only in Japan.
Check for the product ID VXW0002 on the device packaging. The VersaCross RF Wire was only sold in Japan and approved for use there.
Look for the product ID VXW0002 on the device packaging to confirm if it's affected.
No, the device was only approved and sold in Japan.
The sterile pouch could have holes that might lead to infections like sepsis if the device is not properly sterile.
Check for the product ID VXW0002 on the device packaging. This device was only sold in Japan.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2104-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2104-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
