The Optima Coil System consists of an implantable embolization coil compri ...



The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. it is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Optima Coil System and XCEL Detachment Controller(s) are sold separately. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller.
Components:
Recall Date:    Jan 4, 2022
Mfg:
BALT USA, LLC
Mfg Country:
United States
Recall ID:    89338
Product ID:    191293
Enforcement Date:    Mar 2, 2022
Last Published:    Feb 22, 2022

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Emert Number:    Z-0660-2022
Emert Status:    Notified