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News Breaks
February 13, 2013
08:52 EDTSTJFDA 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.
News For STJ From The Last 14 Days
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September 2, 2014
09:57 EDTSTJSt. Jude Medical announces primary outcome two-year data from FAME 2 trial
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September 1, 2014
15:59 EDTSTJSt. Jude Medical announces new Fractional Flow Reserve trial
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August 31, 2014
13:53 EDTSTJSt. Jude Medical Quartet quadripolar lead performed better than bipolar leads
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August 28, 2014
17:42 EDTSTJJ&J begins sales process for its medical device unit Cordis, WSJ says
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August 26, 2014
16:29 EDTSTJSt. Jude Medical resolves FDA warning letter for Plano facility
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