Medical Device Recall: 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
Boston Scientific Corporation · June 11, 2026
Reason for Recall
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.
Distribution
Global Distribution. US Nationwide.
States Affected
NATIONWIDE
Quantity Affected
74,760 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2755-2026
Status: ongoing
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