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SynCardia Companion Driver Caddy Shipping Container
SYNCARDIA SYSTEMS, LLC · Model 397001-001 · UDI-DI 00858000003237
LOZ
Prescription
0
510(k) clearances
3,726
Adverse events (389 deaths)
5
Recalls
3
Facilities
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 audible alarms, resulting |
| 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; resulting in the los |
| 2008-06-13 | Abiomed, Inc. | Subassembly incorrectly aligned |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.