Artificial Heart
FDA product code LOZ · Class 3 · 9 devices · 1,527 reports · 155 deaths reported · 2 devices named in recalls
- SynCardia Freedom® Driver 595000-001Syncardia Systems, LLC · Artificial Heart1 recall7 deaths809 reports
- SynCardia Companion 2 Driver 397002-001Syncardia Systems, LLC · Artificial Heart2 deaths414 reports
- SynCardia temporary Total Artificial Heart System 500101-001Syncardia Systems, LLC · Artificial Heart141 deaths215 reports
- SynCardia Freedom® Onboard Battery 295025-001Syncardia Systems, LLC · Artificial Heart62 reports
- SynCardia 50cc TAH-t, Clinical 570500-001Syncardia Systems, LLC · Artificial Heart1 recall5 deaths5 reports
- SynCardia Companion Hospital Cart 397003-001Syncardia Systems, LLC · Artificial Heart9 reports
- SynCardia Companion Rechargeable LI-ION Battery 293001-001Syncardia Systems, LLC · Artificial Heart8 reports
- SynCardia Companion Driver Caddy 397001-001Syncardia Systems, LLC · Artificial Heart3 reports
- SynCardia Hand Pump 397004-001Syncardia Systems, LLC · Artificial Heart2 reports