5000 Series Freedom Drivers — Class I medical device recall Z-0659-2017
Terminated recall by SynCardia Systems Inc., reported 2016-12-14, distributed in AZ, VA. The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom
| Recall number | Z-0659-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SynCardia Systems Inc., Tucson, AZ, United States |
| Recall initiated | 2016-10-21 |
| Classified | 2016-12-08 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2017-02-21 |
| Distributed | AZ, VA |
| Quantity | 5 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00858000003121 |
| Model numbers | 595000-001 |
Product
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0659-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.