{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Tucson",
      "address_1": "1992 E Silverlake Rd",
      "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.",
      "address_2": "",
      "product_quantity": "56 drivers (21 currently in use on patients)",
      "code_info": "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",
      "center_classification_date": "20150917",
      "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.",
      "state": "AZ",
      "product_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.",
      "report_date": "20150923",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "SynCardia Systems Inc.",
      "recall_number": "Z-2731-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "71905",
      "termination_date": "20151104",
      "more_code_info": "",
      "recall_initiation_date": "20150806",
      "postal_code": "85713-3865",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}