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Event Product Recall / Product Issues / / Facility Service Inpatient Hospital / / IndustryTerm Early devices / arterial and venous occlusive device / self-expandable device / hook device / to covered prescriptions and services / closure devices / congenital heart defect repair devices / transcatheter devices / heart defect repair devices / / MedicalCondition infections producing bacteremia / PDA / atrial septal defects / mechanical fatigue / embolic stroke / cardiac failure / Specific Criteria Congenital heart defect / patent ductus arteriosus / ischemic stroke / infective endarteritis / congenital heart defect / main pulmonary artery / stroke / pulmonary systemic flows / pulmonary vascular resistance / paradoxical embolus / pre-existing thromboembolism / pulmonary hypertension / transient ischemic attack / embolus / recurrent cryptogenic stroke / presumed paradoxical embolism / cryptogenic stroke / Down's syndrome / injury / congenital heart disorder / heart failure / venous thrombus / disorder / patent foramen ovale / endarteritis / thrombus / illness / Amplatzer Patent Foramen Ovale / thrombosis / pulmonary artery / pulmonary veins / Atrial Septal Defect / Active endocarditis / / MedicalTreatment open heart surgery / catheter / open surgery / catheters / bypass / catheterization / drug therapy / surgical treatment / embolization / / Organization Division of Medical Assistance Congenital / Service Inpatient Hospital / U.S. Food and Drug Administration / Division of Medical Assistance Congenital Heart Defect / / Position General / / Product HDE approval / devices / / Technology PDA / / SocialTag