Boston Scientific recalls Torflex Transseptal Guiding Sheath Kits with potential sterile pouch holes causing infection. Affected models include TF85-32-63-45 and TF85-32-63-55. Contact for remedy.
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 specific Torflex Transseptal Guiding Sheath Kits due to a risk of holes in the sterile barrier pouch. This could compromise device sterility and lead to serious infections like sepsis if the kit is used improperly.
The sterile barrier pouch may develop small holes that could allow contamination. These holes might go undetected during procedures because they are small and can occur in various locations. If the pouch is compromised, the device may not be sterile, increasing the risk of infection.
Healthcare professionals using the Torflex kits for cardiac procedures are most at risk. Patients receiving procedures with these kits could face infection if the sterile barrier is compromised.
Check for model numbers TF85-32-63-45 or TF85-32-63-55 on the kit packaging. The kits are sold with specific lot numbers listed in the recall notice.
Identify the model number on the kit packaging to confirm if it is affected.
Reach out to Boston Scientific for instructions on how to handle the recalled kit.
The affected models are TF85-32-63-45 and TF85-32-63-55.
Look for the model numbers TF85-32-63-45 or TF85-32-63-55 on the packaging.
Contact Boston Scientific for instructions on how to handle the kit.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2106-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2106-2025 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.
