Boston Scientific Corporation - Lotus Valve System - Class 1 Recall
Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2015 Category: Medical Equipment Source Type: alerts
Boston Scientific Corporation - Lotus Valve System - Class 1 Recall
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2015 Category: Medical Equipment Source Type: alerts
Boston Scientific Corporation - Lotus Valve System - Class 1 Recall
Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV250, Catalog Number LTV25; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2015 Category: Medical Equipment Source Type: alerts
Edwards Lifesciences, LLC - Edwards Lifesciences Vent Catheters - Class 2 Recall
Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle. Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term ( 6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle. Extracorporeal circuit components with a Duraflo coating are intended for use in cardi...
Source: Medical Device Recalls - November 15, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Cardiovascular Surgery-the Heart Valve Division - Hancock Apical Left Ventricular Connector (LV Connector) - Class 2 Recall
Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Cardiovascular Surgery-the Heart Valve Division - Model 7305 Mosaic Aortic Obturator - Class 2 Recall
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2014 Category: Medical Equipment Source Type: alerts
