Temporary Total Artificial Heart (TAH-t) with Freedom Driver System
Medical device recall Z-2731-2015. Published in FDA’s Enforcement Report on Sep 23, 2015.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 23, 2015. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 8 states named
- 56 drivers (21 currently in use on patients) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
56 drivers (21 currently in use on patients), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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…
FDA’s list runs to 2,784 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- Arkansas
- California
- Michigan
- North Carolina
- Ohio
- Pennsylvania
- Texas
- Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 6, 2015.
- FDA classified it on Sep 17, 2015.
- FDA’s Enforcement Report published it on Sep 23, 2015.
- FDA terminated it on Nov 4, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- SynCardia Systems Inc., of Tucson, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,784 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.