Boston Scientific recalls FARADRIVE Steerable Sheath Clear IDE devices due to potential air embolism from hemostatic valve damage during improper insertion. Affected units have specific material and lot numbers.
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 FARADRIVE Steerable Sheath Clear IDE devices that may have hemostatic valve damage from improper insertion. This could lead to air embolism, a serious risk during heart procedures.
Improper insertion of the dilator through the valve can damage the hemostatic valve. This damage may allow air to enter the bloodstream, causing air embolism which can harm patients during heart procedures.
Healthcare professionals using the device for heart procedures are most at risk. Patients undergoing these procedures may be affected if the device is used improperly.
Check for Material Number 21C6: 21C602, IFU Reference Number 51636751-01, and lots CL12910, CL12978, CL15153. The device is used for heart procedures and vasculature access.
Verify the Material Number (21C602), IFU Reference Number (51636751-01), and lot numbers (CL12910, CL12978, CL15153) to confirm if your device is affected.
Improper insertion of the dilator can damage the hemostatic valve, potentially causing air embolism during heart procedures.
Check for Material Number 21C602, IFU Reference Number 51636751-01, and lot numbers CL12910, CL12978, or CL15153.
The recall does not provide a remedy; proper insertion technique can mitigate the risk.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2754-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2754-2026 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.
