Boston Scientific Corporation — FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 5163

⚠️ 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.