🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: August 6, 2015 SynCardia Systems Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
SynCardia Systems Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2731-2015

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