Recall Z-0659-2017— SynCardia Systems Inc.
Class I · Terminated
Class I FDA medical device recall by SynCardia Systems Inc., initiated 2016-10-21, terminated 2017-02-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001. 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..
- Recalling firm
- SynCardia Systems Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-10-21
- Terminated
- 2017-02-21
- Firm location
- Tucson, AZ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.