{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "cfres_id": "197491",
      "product_res_number": "Z-1022-2023",
      "event_date_initiated": "2022-11-02",
      "event_date_posted": "2023-01-27",
      "recall_status": "Open, Classified",
      "res_event_number": "91330",
      "product_code": "LOZ",
      "pma_numbers": [
        "P030011"
      ],
      "product_description": "SynCardia Total Artificial Heart System (70CC): 500101-001\n\nSynCardia Total Artificial Heart System (50CC): 570500-000",
      "code_info": "SynCardia Total Artificial Heart System (70CC): 500101-001\n\n\nSynCardia Total Artificial Heart System (50CC): 570500-000",
      "firm_fei_number": "3003761017",
      "recalling_firm": "SynCardia Systems LLC",
      "address_1": "1992 E Silverlake Rd",
      "city": "Tucson",
      "state": "AZ",
      "postal_code": "85713-3865",
      "additional_info_contact": "Elizabeth Oei\n520-276-5037",
      "reason_for_recall": "Due to tears reported tears in the cannula due to wear and tear stress.",
      "root_cause_description": "Device Design",
      "action": "On 11/02/2022, the firm send an \"Urgent Medical Device Correction\" Letter via email alerting customers that there is the potential for hole or tear that may occur in the pneumatic cannulae of the temporary Total Artificial Heart (TAH-t).\n\nCustomers are instructed to:\nPrior to a hole/tear occurring, train patients to properly inspect the cannulae for holes/ tears and to recognize the signs of a tear/hole. If a hole/tear occurs, the patient should immediately call the hospital to arrange for repair.\n\nFor Clinicians Only:\nWhile SynCardia has not validated the below instructions, there have been literature articles[i][ii] on this method to repair a cannula tear by removing the damaged cannula segment. The repair requires a backup Companion 2 or Freedom portable driver, a secondary driver driveline connector, zip ties, and high-leverage cable cutters. The repair should be implemented quickly by at least two operators following the instructions below. One operator will prepare and operate the backup driver. A second operator will cut and reconnect the cannula.\n1. Inspect cannulae for any sign of a tear, hole, or cut, which can be visually detected or detected by listening for a hissing sound or whooshing of air.\n2. Prepare a backup driver with an appropriate secondary connector attached to the affected driver driveline. Power on the selected backup driver and keep it on standby for the next repair steps.\n3. Using a high-leverage cable cutter cut the cannula through the coil wire slightly distal to the tear to minimize the loss of cannula length. Insert a secondary connector barb (connected to the powered backup driver) into the cut cannula. Secure the cannula to the new connector with zip ties.\n4. Disconnect the other undamaged cannula from the primary driver and reconnect it to the backup driver.\n5. Change backup driver from standby to run with the correct settings for the patient.\n\nFor questions contact Customer Support Manager at 1-866-480-1122.\n\nIn addition to custome",
      "product_quantity": "1,732 systems",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.",
      "openfda": {
        "pma_number": [
          "P030011"
        ],
        "registration_number": [
          "3003761017",
          "1721676",
          "3003174284"
        ],
        "fei_number": [
          "3003761017",
          "1721676",
          "3003174284"
        ],
        "device_name": "Artificial Heart",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}