Recall Z-2731-2015 ยท LOZ Artificial Heart
SynCardia Systems Inc.
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.
| Date | Sep 17, 2015 (initiated Aug 6, 2015) |
| Status | Terminated |
| Reason | SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function. |
| Root cause | Component design/selection |
| Action | SynCardia sent an Urgent Medical Device Recall letter dated August 6, 2015 to affected customers. The letter identified the purpose, reason for the voluntary recall, risk to health, how to recognize that the device may fail, actioms to be taken by the customer/user, product and distribution information and type of action by the company. Customer were instructed to completed and return Recall Acknowledgement and Receipt Form to SynCardia. A SynCardia Clinical Support Specialist or other SynCardia representative will assist customers with replacement product and returning affected product. |
| Quantity | 56 drivers (21 currently in use on patients) |
| Distribution | Worldwide Distribution -- US Nationwide in the states of AR, NC, CA, OH, PA, TX, MI, and VA; and the countries of Germany, Turkey and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.