Boston Scientific recalls VersaCross Access Solution (VXSK) products due to potential hole in sterile barrier pouch, risking infection. Affected units include specific model IDs and batch numbers listed in the 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 Access Solution (VXSK) products because a hole in the sterile barrier pouch could compromise device sterility, potentially leading to serious infections like sepsis. This risk is especially concerning in clinical settings where small punctures might go unnoticed.
The sterile barrier pouch may develop small holes that could allow contamination, risking infection. In severe cases, this might lead to sepsis. These punctures are small and could be missed during routine checks in clinical settings.
Healthcare professionals using the VersaCross Access Solution during medical procedures are most at risk. Patients receiving these devices could face infection if the sterile barrier is compromised.
Check for product IDs starting with VXSK followed by model numbers like VXSK0101, VXSK0102, etc. Also look for specific batch numbers listed in the recall notice, such as Lot 35590858.
Look for model numbers like VXSK0101, VXSK0102, or VXSK0134 on the product packaging.
Check the batch numbers listed in the recall notice, such as Lot 35590858 or Lot 35893570.
The sterile barrier pouch may have small holes that could compromise device sterility, potentially leading to infections like sepsis in clinical settings.
Check for product IDs starting with VXSK followed by model numbers like VXSK0101, VXSK0102, or VXSK0134, and batch numbers such as Lot 35590858.
No, the recall does not require immediate discontinuation. Affected users should check their product IDs and batch numbers to confirm if they are impacted.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2103-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2103-2025 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.
