Recall Z-0659-2017 ยท LOZ Artificial Heart
SynCardia Systems Inc.
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
| Date | Oct 21, 2016 |
| 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. |
| Root cause | Process control |
| Action | On 10/21/16 customers were notified by phone. Customers were informed that patients who were being supported by affected Drivers must be switched to unaffected Drivers. The firm will provide unaffected Freedom Drivers to replace the affected Drivers. Affected Drivers must be return to the firm. Instructions for return provided, and Acknowledgment Form must be completed. Contact Information For Questions Mary Pat Sloan Senior Vice President Global Certification and Logistics SynCardia Systems, LLC 1992 E Silverlake Rd Tucson, AZ 85713 Direct 520-547-7470 Toll-free 866-480-1122 Ext 1308 Mon |
| Quantity | 5 |
| Distribution | US distribution to Virginia and Arizona. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.