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Medtronic Cardiovascular Surgery-the Heart Valve Division recalls Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aorti
Recalled February 12, 2014 · FDA recall Z-0908-2014 · Medtronic Cardiovascular Surgery-the Heart Valve Division
Hazard
Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-expected transvalvular gradients occurring post implant. · FDA Class II
Units
8276 units
Sold at
Worldwide Distribution - USA (nationwide)
Description
Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-expected transvalvular gradients occurring post implant.
Product
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
Manufacturer(s)
Medtronic Cardiovascular Surgery-the Heart Valve Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →