Boston Scientific recalls VersaCross Transseptal Sheath Kits (VXS0201, VXS2112) due to potential hole in sterile barrier pouch risking infection. Affected units sold in specific lots.
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 certain VersaCross Transseptal Sheath Kits because a hole in the sterile pouch could compromise device sterility, potentially causing serious infections. This risk is especially concerning in medical procedures where sterility is critical.
The sterile barrier pouch may develop small holes that could allow contamination. These holes might go undetected during procedures because they're small and can occur in various locations. If the sheath isn't sterile, it could lead to serious infections like sepsis.
Healthcare professionals using the recalled sheath kits for cardiac procedures are most at risk. Patients undergoing procedures with these kits could face infection if the sterility is compromised.
Check for product IDs VXS0201 or VXS2112 on the kit. The kits were sold with specific lots: Lot 35800622 for VXS0201 and Lot 35892045 for VXS2112.
Look for product IDs VXS0201 or VXS2112 on the sheath kit.
Contact Boston Scientific directly for further instructions if you have the recalled product.
The sterile barrier pouch may develop small holes that could compromise sterility, potentially leading to infections like sepsis if the sheath isn't properly sterile during procedures.
Check for product IDs VXS0201 or VXS2112 with specific lots: Lot 35800622 for VXS0201 and Lot 35892045 for VXS2112.
The recall does not require immediate stop use; healthcare professionals should check product IDs and contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2105-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2105-2025 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.
