Medtronic Inc - Hancock II T510 Bioprosthesis - Class 2 Recall
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2019 Category: Medical Devices Source Type: alerts
Medtronic Inc - Mosaic 310 Bioprosthesis - Class 2 Recall
Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2019 Category: Medical Devices Source Type: alerts
Medtronic Inc - Hancock II T510 Bioprosthesis - Class 2 Recall
Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2019 Category: Medical Devices Source Type: alerts
Medtronic Inc - Mosaic 310 Bioprosthesis - Class 2 Recall
Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2019 Category: Medical Devices Source Type: alerts
CryoLife, Inc. - OnX Aortic Heart Valve - Class 2 Recall
On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X¿ Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for i...
Source: Medical Device Recalls - March 29, 2019 Category: Medical Devices Source Type: alerts
Genesee BioMedical, Inc. - Sternal Valve Retractor - Class 2 Recall
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 30, 2018 Category: Medical Devices Source Type: alerts
Edwards Lifesciences, LLC - Certitude Delivery System - Class 1 Recall
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) or transaortic (TAo) approach to transcatheter aortic valve replacement. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2018 Category: Medical Devices Source Type: alerts
CryoLife, Inc. - OnX Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft - Class 2 Recall
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2017 Category: Medical Devices Source Type: alerts
CryoLife, Inc. - bileaflet mechanical heart valve - Class 2 Recall
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 13, 2017 Category: Medical Devices Source Type: alerts
Sorin Group USA, Inc. - Perceval Sutureless Heart Valve - Class 2 Recall
Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 8, 2016 Category: Medical Equipment Source Type: alerts
Medtronic Cardiovascular Surgery-the Heart Valve Division - COREVALVE EVOLUT R SYSTEM - Class 2 Recall
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 17, 2016 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - HX2 Temperature Management Systems - Class 2 Recall
HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right).The system has the capacity to circulate water at a rate of up to 6.5 gal.min (25 L/min) with no load conne...
Source: Medical Device Recalls - July 15, 2016 Category: Medical Equipment Source Type: alerts
Aesculap, Inc. - Valve XS Atrium Retractable - Class 2 Recall
Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 1, 2016 Category: Medical Equipment Source Type: alerts
Medtronic Cardiovascular Surgery-the Heart Valve Division - Medtronic EnVeo R Loading System - Class 1 Recall
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2015 Category: Medical Equipment Source Type: alerts
