Boston Scientific Corporation — Class II: FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into th
Boston Scientific has identified a risk of hemostatic valve damage in a subset of FARADRIVE Steerable Sheaths caused by improper dilator insertion orientation during preparation. Such damage can lead to air ingress and potential air embolism during medical procedures.
Boston Scientific Corporation and clinical personnel utilizing the FARADRIVE Steerable Sheath (Material Number 21M402) for vascular and cardiac chamber access.
This Class II recall highlights a critical intersection between device design and user technique during the preparation phase. The source indicates that the risk of air embolism—a serious patient safety concern—is tied to mechanical damage during setup, suggesting that regulatory and quality teams may need to evaluate if mechanical tolerances or labeling instructions sufficiently mitigate user error during dilator advancement.
QA and clinical teams should verify that existing Instructions for Use (IFU) or training materials specifically address the orientation and centering of dilators during insertion. Regulatory teams should monitor post-market surveillance for similar trends in hemostatic valve damage to determine if current device preparation protocols require formal revision or additional clinician education.
Class II. Reason: 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.. Product: FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062. Firm: Boston Scientific Corporation (Saint Paul MN United States). Status: Ongoing.
Open in openFDA / FDA.gov