Class I — SynCardia Systems Inc.
| Recalling firm | SYNCARDIA SYSTEMS, LLC |
|---|---|
| Registered facility | SYNCARDIA SYSTEMS, LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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 in the loss of life-sustaining function. |
| Product | 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001 |
| Quantity | 5 |
| Distribution | US distribution to Virginia and Arizona. |
| Initiated | 2016-10-21 |
| Classified | 2016-12-08 |
| Terminated | 2017-02-21 |
| Recall number | Z-0659-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — SynCardia Systems Inc. (Z-0659-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75600/
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