Date Initiated by Firm |
August 06, 2015 |
Date Posted |
September 17, 2015 |
Recall Status1 |
Terminated 3 on November 04, 2015 |
Recall Number |
Z-2731-2015 |
Recall Event ID |
71905 |
PMA Number |
P030011 |
Product Classification |
Artificial heart - Product Code LOZ
|
Product |
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. |
Code Information |
Part Number: 595000-001 Motor Gearbox Serial # CGI Lot # SynCardia Lot # Freedom Driver Serial # 85979-013 85979 031479 4506 85979-022 85979 031479 4506 85977-033 85977 031333 4507 85976-020 85976 031041 4514 85976-010 85976 030944 4517 85976-014 85976 030944 4517 85979-014 85979 031479 4517 85979-021 85979 031479 4517 85976-039 85976 031074 4521 85977-001 85977 031074 4521 85978-034 85978 031823 4521 85978-040 85978 031823 4521 85977-020 85977 031333 4542 85977-032 85977 031333 4542 85979-005 85979 031452 4546 85979-012 85979 031452 4546 85979-018 85979 031479 4559 85979-024 85979 031479 4559 85976-016 85976 031041 4573 85976-026 85976 031041 4573 85977-005 85977 031140 4592 85977-008 85977 031140 4592 85977-021 85977 031333 4593 85977-025 85977 031333 4593 85979-004 85979 031452 4635 85979-007 85979 031452 4635 85979-033 85979 031823 4642 85979-026 85979 031479 4645 85979-028 85979 031479 4645 85979-017 85979 031479 4653 85979-019 85979 031479 4653 85977-026 85977 031333 4661 85978-026 85978 031623 4677 85978-032 85978 031623 4677 85977-019 85977 031405 4681 85978-018 85978 031623 4700 85978-022 85978 031623 4700 85977-012 85977 031255 4720 85978-020 85978 031623 4722 85978-025 85978 031623 4722 85976-006 85976 031041 4732 85977-006 85977 031140 4756 85978-035 85978 031823 4763 85976-001 85976 030944 4782 85976-003 85976 030944 4782 85976-037 85976 031057 4784 85976-040 85976 031057 4784 85976-030 85976 031074 4785 85976-036 85976 031074 4785 85976-022 85976 031074 4788 85976-024 85976 031074 4788 85976-015 85976 031074 4790 85976-038 85976 031074 4790 85976-023 85976 031074 4791 85976-032 85976 031074 4791 85977-015 85977 031333 4792 85977-028 85977 031333 4792 85977-030 85977 031333 4793 85977-013 85977 031333 4794 85977-023 85977 031333 4794 85977-016 85977 031333 4796 85977-031 85977 031333 4796 85977-010 85977 031405 4797 85977-011 85977 031405 4797 85977-009 85977 031405 4798 85977-037 85977 031406 4798 85977-003 85977 031405 4799 85977-034 85977 031405 4799 85977-035 85977 031406 4800 85977-036 85977 031406 4800 85978-037 85978 031823 4800 85977-039 85977 031406 4801 85977-040 85977 031406 4801 85979-011 85979 031452 4802 85978-002 85978 031487 4806 85978-004 85978 031487 4806 85978-003 85978 031487 4808 85978-006 85978 031487 4808 85979-029 85979 031541 4809 85979-031 85979 031541 4809 85978-010 85978 031541 4810 85979-038 85979 031541 4810 85978-009 85978 031541 4811 85979-034 85979 031541 4811 85979-032 85979 031541 4812 85979-035 85979 031541 4812 85978-008 85978 031541 4813 85979-036 85979 031541 4813 85978-016 85978 031623 4814 85978-021 85978 031623 4814 85978-013 85978 031623 4815 85978-024 85978 031623 4815 85978-027 85978 031623 4817 85978-030 85978 031623 4817 85978-017 85978 031623 4818 85978-029 85978 031623 4818 |
Recalling Firm/ Manufacturer |
SynCardia Systems Inc. 1992 E Silverlake Rd Tucson AZ 85713-3865
|
For Additional Information Contact |
520-545-1234
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
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.
Contact Information For Questions
Mary Pat Sloan
Senior Vice President
Global Certification and Logistics
SynCardia Systems, Inc
1992 E Silverlake Rd
Tucson, AZ 85713
Direct 520-547-7470
Toll-free 866-480-1122 Ext 1308
Monday-Friday 7:30 AM to 5:00 PM Pacific/Arizona time
Hotline 24/7 866-771-9437
www.syncardia.com |
Quantity in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
PMA Database |
PMAs with Product Code = LOZ and Original Applicant = SYNCARDIA SYSTEMS, LLC
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