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Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart
Recalled July 29, 2026 · FDA recall Z-2756-2026 · Boston Scientific
Hazard
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. · FDA Class II
Units
508,151 units
Sold at
Global Distribution. US Nationwide.
Description
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) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →