{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "48148",
      "product_res_number": "Z-0004-2007",
      "event_date_initiated": "2006-08-25",
      "event_date_posted": "2006-10-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-11-27",
      "res_event_number": "36186",
      "product_code": "DSQ",
      "pma_numbers": [
        "P870072S012"
      ],
      "product_description": "Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000\n\nDistributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588",
      "code_info": "All Codes (Valve Disk Lot 20052904)",
      "firm_fei_number": "2916596",
      "recalling_firm": "Thoratec  Corp",
      "address_1": "6035 Stoneridge Drive",
      "city": "Pleasanton",
      "state": "CA",
      "postal_code": "94588",
      "additional_info_contact": "Gary Cederwall\n925-730-4118",
      "reason_for_recall": "Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.",
      "root_cause_description": "Other",
      "action": "On 8/26/06, the firm issued letters to all its direct consignees, informing them of the affected product and providing 'IMPORTANT PRODUCT SAFETY BULLETIN'.",
      "product_quantity": "114 devices (57 valves/2 per unit)",
      "distribution_pattern": "Worldwide distribution-USA including states of AL, CA, CT, FL, IL, IN, KY, LA, MA, ME, MI, MN, NC, NY, OH, PA, TN, TX, VA, WA, and WI., with 19 Foreign consignees Australia, Belgium, Canada*, Czech Republic, France, Germany, Ireland, Netherlands, Portugal, Switzerland, United Kingdom. (*Hospital Royal Victoria, Queen Elizabeth II/Capital Health, St. Paul's Hospital, Vancouver, Canada.)--",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
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          "P920014",
          "P870072",
          "P160035",
          "P900023",
          "P100047",
          "P160054",
          "P980012",
          "P060040"
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