BEUDAMED
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    Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code HCG·September 7, 2022

    Optima Coil System Model OPTI0520CSF10. For endovascular embolization.

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code HCG·July 26, 2022

    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.

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code HCG·January 4, 2022