Boston Scientific recalls FARADRIVE Steerable Sheaths with specific lot numbers due to potential hemostatic valve damage causing air embolism. Affected units may need reinsertion checks to prevent patient harm.
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
Boston Scientific is recalling certain FARADRIVE Steerable Sheaths that could have valve damage during insertion, risking air embolism. This is serious but can be fixed by inserting the device straight through the valve.
If the device is inserted incorrectly, the hemostatic valve can get damaged. This may let air enter the bloodstream, causing air embolism which can harm patients.
Heart surgery patients and medical professionals using the device. Those with the specific lot numbers are most at risk.
Check the lot numbers listed in the recall: CL12917 through CL15776. The product is used in heart procedures and has a specific material number (M004PFCE21M402).
Insert the dilator straight through the center of the valve and fully advance it into the sheath body to prevent valve damage.
Boston Scientific is recalling FARADRIVE Steerable Sheaths with specific lot numbers due to potential valve damage that could cause air embolism during heart procedures.
Check the lot numbers listed in the recall: CL12917 through CL15776. The product has material number M004PFCE21M402 and is used in heart procedures.
Yes, by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body to prevent valve damage.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2757-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2757-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
