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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71905

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 06, 2015
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
SynCardia Systems Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2731-2015
Recall number
Z-2731-2015
Initiated
August 06, 2015
Classification
Class I
Status
Terminated
Recalling firm
SynCardia Systems Inc.
Quantity
56 drivers (21 currently in use on patients)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

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.