FDA announced Class I recall of St. Jude's Amplatzer delivery system The FDA yesterday afternoon announced a Class I recall for St. Jude Medical's Amplatzer TorqVue FX Delivery System. The Amplatzer system is used to assist the attachment, loading, delivery, and deployment of Amplatzer Occluder devices. Amplatzer Occluder devices are used to close openings between the two upper chambers of the heart. The FDA stated that in a small number of cases, the distal end of the core wire of the TorqVue FX Delivery System could potentially fracture. The product may cause serious adverse health consequences, including death, the agency added.
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