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Artificial Heart
FDA product code LOZ · Class 3 · Unknown
26
Registered devices
3,691
Adverse events
5
Recalls
0
510(k) clearances
Devices with this code
SynCardia Freedom® Hospital AC Power Supply — SYNCARDIA SYSTEMS, LLCSynCardia Companion Battery Shipping Container — SYNCARDIA SYSTEMS, LLCSynCardia Companion Hospital Cart — SYNCARDIA SYSTEMS, LLCSynCardia Freedom® Battery Charger — SYNCARDIA SYSTEMS, LLCSynCardia Hand Pump — SYNCARDIA SYSTEMS, LLCSynCardia temporary Total Artificial Heart System — SYNCARDIA SYSTEMS, LLCSynCardia Freedom® Standby Kit Shipping Container — SYNCARDIA SYSTEMS, LLCSynCardia Freedom® Car Charger — SYNCARDIA SYSTEMS, LLCSynCardia Freedom® Battery Charger Set Shipping Container — SYNCARDIA SYSTEMS, LLCSynCardia 50cc TAH-t, Clinical — SYNCARDIA SYSTEMS, LLCSynCardia Freedom® Discharge Kit Shipping Container — SYNCARDIA SYSTEMS, LLCSynCardia Freedom® Driver — SYNCARDIA SYSTEMS, LLCSynCardia Companion AC Input Power Cord — SYNCARDIA SYSTEMS, LLCSynCardia Companion Driver Caddy Shipping Container — SYNCARDIA SYSTEMS, LLCSynCardia Companion Rechargeable LI-ION Battery — SYNCARDIA SYSTEMS, LLCSynCardia Companion Drivelines — SYNCARDIA SYSTEMS, LLCSynCardia Freedom® Onboard Battery — SYNCARDIA SYSTEMS, LLCSynCardia Freedom® Home AC Power Supply — SYNCARDIA SYSTEMS, LLCSynCardia Freedom® Power Adaptor — SYNCARDIA SYSTEMS, LLCSynCardia 50cc TAH-t Surgical Spares Kit — SYNCARDIA SYSTEMS, LLCSynCardia Companion Driver Shipping Container — SYNCARDIA SYSTEMS, LLCSynCardia Hand Pump Shipping Container — SYNCARDIA SYSTEMS, LLCSynCardia 70cc TAH-t Surgical Spares Kit — SYNCARDIA SYSTEMS, LLCSynCardia Companion 2 Driver — SYNCARDIA SYSTEMS, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-01 | SynCardia Systems LLC | Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. |
| 2022-11-02 | SynCardia Systems LLC | Due to tears reported tears in the cannula due to wear and tear stress. |
| 2016-10-21 | SynCardia Systems Inc. | The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audib |
| 2015-08-06 | SynCardia Systems Inc. | SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; |
| 2008-06-13 | Abiomed, Inc. | Subassembly incorrectly aligned |
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