Drug recall
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number…
FDA recall event 75600 · Class I · SynCardia Systems Inc.
Key facts
| Event ID | 75600 |
|---|---|
| Recall numbers | Z-0659-2017 |
| Recalling firm | SynCardia Systems Inc. |
| Product type | Devices |
| Products | 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Oct 21, 2016 |
| Report date | Dec 14, 2016 |
| Termination date | Feb 21, 2017 |
| City | Tucson |
| State | AZ |
| Country | United States |
| FEI number | 3003761017 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: