Boston Scientific recalls FARADRIVE Steerable Sheath (Clear) due to potential valve damage causing air embolism. Affected units have specific lot numbers; users should check if their device matches the recall list.
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 a specific type of steerable sheath used in heart procedures because improper handling can damage a valve, leading to air entering the bloodstream and potential patient harm. The risk is mitigated by inserting the device straight through the valve and fully advancing it.
If the dilator is not inserted straight through the center of the valve during preparation, it can damage the valve. This damage may allow air to enter the bloodstream, potentially causing air embolism and patient harm.
Healthcare professionals using the FARADRIVE Steerable Sheath (Clear) for heart procedures are most at risk. Patients receiving these procedures may be affected if the device is used incorrectly.
Check if your FARADRIVE Steerable Sheath (Clear) has the lot numbers listed in the recall (e.g., CL12695, CL12696, etc.). The device is used for heart procedures and has a specific material number (M004PF21M402).
Identify if your sheath has a lot number from the recall list (e.g., CL12695, CL12696, etc.).
Insert the dilator straight through the center of the valve and fully advance it into the sheath body to prevent valve damage.
Boston Scientific identified that improper insertion of the dilator during preparation can damage the hemostatic valve, potentially causing air embolism and patient harm.
Check if your sheath has a lot number from the recall list (e.g., CL12695, CL12696, etc.). The device is used for heart procedures and has a specific material number (M004PF21M402).
Insert the dilator straight through the center of the valve and fully advance it into the sheath body to prevent valve damage. This reduces the risk of air embolism.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2756-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2756-2026 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.
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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.
