FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
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 OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
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: 00191506042516Model Lots: CL12917Model CL13004Model CL13017Model CL13046Model CL13060Model CL13080Model CL13103Model CL13122Model CL13123Model CL13142Model CL13160Model CL13196Model CL13212Model CL13219Model CL13231Model CL13260Model CL13291Model CL13340Model CL13375Model CL13401Model CL13422Model CL13468Model CL13519Model CL13573UPC 00191506042516Would you have heard about this one?
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