Edwards Lifesciences, LLC - Edwards Commander Delivery System - Class 2 Recall
Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008 Product Usage: The Edwards SAPIEN 3 THV, Edwards Commander delivery system and accessories are indicated for use in patients with severe, symptomatic, calcific aortic stenosis (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2019 Category: Medical Devices Source Type: alerts
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
