SynCardia Systems Inc. - Temporary Total Artificial Heart (TAHt) with Freedom - Class 1 Recall
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2015 Category: Medical Equipment Source Type: alerts
Musculoskeletal Transplant Foundation, Inc. - MTF Cortical Pin - Class 2 Recall
Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 25, 2015 Category: Medical Equipment Source Type: alerts
Musculoskeletal Transplant Foundation, Inc. - Musculoskeletal Transplant Foundation Allofix Insertion Kit - Class 2 Recall
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2015 Category: Medical Equipment Source Type: alerts
HeartWare Inc - HeartWare Ventricular Assist System (HVAD) - Class 2 Recall
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
HeartWare Inc - HeartWare Ventricular Assist System - Class 1 Recall
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 14, 2015 Category: Medical Equipment Source Type: alerts
HeartWare Inc - HeartWare Ventricular Assist System - Class 1 Recall
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2015 Category: Medical Equipment Source Type: alerts
HeartWare Inc - HeartWare Ventricular Assist System (HVAD) - Class 2 Recall
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2015 Category: Medical Equipment Source Type: alerts
HeartWare Inc - HeartWare Ventricular Assist System - Class 1 Recall
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 9, 2015 Category: Medical Equipment Source Type: alerts
Diasorin Inc. - PROTrac II Tacrolimus ELISA kit - Class 2 Recall
DiaSorin, PRO-Trac" II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 21, 2015 Category: Medical Equipment Source Type: alerts
Musculoskeletal Transplant Foundation, Inc. - Musculoskeletal Transplant Foundation DBX Demineralized Bone Matrix Mix - Class 2 Recall
DBX Mix, 20 cc Prod Code: 058200 Aseptically packaged in a sterilized glass jar with a screw top lid which is then sealed in the Aclar/PETG Lyo jar tray with a foil lid. The tray is then labeled and put into a box. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2015 Category: Medical Equipment Source Type: alerts
HeartWare Inc - HeartWare Ventricular Assist System - Class 1 Recall
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 26, 2015 Category: Medical Equipment Source Type: alerts
Zimmer, Inc. - Zimmer Patellofemoral Joint (PFJ) Prosthesis - Class 2 Recall
Gender Solution Patello-Femoral Joint System Patello-Femoral Trochlea Component, Precoat, Size 4, Left Product Usage: The Zimmer Patellofemoral Joint (PFJ) Prosthesis is designed to closely replicate the anatomic features of the patellar groove on the femur. The implant s articulating surface incorporates the NexGen¿ knee system s frontal profile geometry for optimal patella tracking for both resurfaced and unresurfaced patellae. The construct of the PFJ prosthesis accommodates a wide range of patients, both female and male. Five sizes in left and right configurations are being offered for this implant. Intended...
Source: Medical Device Recalls - August 27, 2014 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Dimension Vista CSA and CSAE - Class 2 Recall
Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2014 Category: Medical Equipment Source Type: alerts
HeartWare Inc - HeartWare Ventricular Assist System - Class 2 Recall
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2014 Category: Medical Equipment Source Type: alerts
HeartWare Inc - Heartware HVAD Pump Implant Kit - Class 1 Recall
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 24, 2014 Category: Medical Equipment Source Type: alerts
