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
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, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
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: 00810087180072Model Lots: CL12697Model CL12698Model CL12701Model CL12702Model CL12824Model CL12832Model CL12833Model CL12861Model CL12888Model CL12889Model CL12912Model CL12913Model CL12916Model CL12918Model CL12968Model CL12975Model CL12977Model CL13003Model CL13016Model CL13019Model CL13045Model CL13047Model CL13059Model CL13078UPC 00810087180072Would you have heard about this one?
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