Heartware, Inc.: Medical Device Recalls in 2020

According to to data from the FDA, there were 7 medical device recalls made by Heartware, Inc. in 2020. See the details of the recalls below.

You can see similar recalls for other firms.

• HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
• HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
• Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
• Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
• Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
• Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
• Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP