{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "87750",
      "product_res_number": "Z-0824-2010",
      "event_date_initiated": "2009-12-16",
      "event_date_posted": "2010-03-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-07-02",
      "res_event_number": "54167",
      "product_code": "DSQ",
      "pma_numbers": [
        "P900023"
      ],
      "product_description": "Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000.  Manufactured by Abiomed, Inc. Danvers, MA.\n\nIntended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.",
      "code_info": "Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.",
      "firm_fei_number": "1220648",
      "recalling_firm": "Abiomed, Inc.",
      "address_1": "22 Cherry Hill Dr",
      "city": "Danvers",
      "state": "MA",
      "postal_code": "01923",
      "additional_info_contact": "Michael O'hara \n978-646-1543",
      "reason_for_recall": "Console shut down with no audible alarm",
      "root_cause_description": "Process control",
      "action": "Abiomed initiated the recall by telephone contact and followed with a Recall Letter dated January 27, 2010.  Consignees were informed that a Field Service Engineer will be in contact and schedule a time to visit and correct the affected device.\n\nFor further information, contact Abiomed Quality Assurance at 1-978-656-1543 or Abiomed Field Service at 1-800-554-8666.",
      "product_quantity": "496 units",
      "distribution_pattern": "Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P870072",
          "P900023",
          "P170038",
          "P100047",
          "P980012",
          "P060040",
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          "P160054",
          "P920014"
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