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
Boston Scientific Corporation
The 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 recall.
The remedy
Follow FDA guidance
About this recall
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
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI-DI: 00191506043131Model Lots: CL12695Model CL12696Model CL12699Model CL12700Model CL12703Model CL12808Model CL12816Model CL12817Model CL12823Model CL12834Model CL12835Model CL12836Model CL12853Model CL12860Model CL12882Model CL12883Model CL12884Model CL12891Model CL12907Model CL12908Model CL12909Model CL12919Model CL12949Model CL12950UPC 00191506043131Would you have heard about this one?
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