{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "cfres_id": "178297",
      "product_res_number": "Z-0955-2020",
      "event_date_initiated": "2019-11-21",
      "event_date_posted": "2020-02-07",
      "recall_status": "Open, Classified",
      "res_event_number": "84430",
      "product_code": "OZO",
      "pma_numbers": [
        "P150001"
      ],
      "product_description": "Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754,  and MMT-1755 \n*US and Canada Version Only",
      "code_info": "All Serial Numbers ( excluding devices with black retainer rings)",
      "firm_fei_number": "3003166194",
      "recalling_firm": "Medtronic Inc.",
      "address_1": "18000 Devonshire St",
      "city": "Northridge",
      "state": "CA",
      "postal_code": "91325-1219",
      "additional_info_contact": "Khristina Anastasopoulos\n818-576-3398",
      "reason_for_recall": "There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.",
      "root_cause_description": "Device Design",
      "action": "On November 21, 2019, Medtronic initiated a recall of MiniMed 600 series insulin pumps with a clear retainer ring design.  On October 5, 2021, the firm expanded the recall and issued an \"Urgent Field Safety Notification\" to all patients and health care providers. The updated notification informs consignees that Medtronic will proactively replace all MiniMed 600 series insulin pumps that have a clear retainer ring design with an equivalent pump that has the updated black retainer ring design. Pumps will be replaced at no charge over the coming months even if the retainer ring is not damaged and regardless of the warranty status of the pump.  In addition to providing consignees with this updated recall strategy, the firm asked consignees to take the following actions: \n \nACTIONS REQUIRED BY YOU:\n1.\tComplete and return the attached Confirmation Form to acknowledge that you have reviewed and understood this notification. \n\n2.\tMedtronic is requesting patients visit [www.medtronicdiabetes.com/PumpRing] and complete the form online, or call us at 1-877-585-0166 to indicate their decision to receive a replacement pump at no charge. Replacement pumps will become available in the coming months and patients will be notified when their pump is ready to ship. Please assist patients in making replacement decision considering the safety risk associated with the retainer ring issue.\n\nFor additional recall details, please view the following link: \n https://www.medtronicdiabetes.com/customer-support/product-and-service-updates/notice15-letter",
      "distribution_pattern": "US:AK,AL,AR,AZ,BM,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,  NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY\n\nOUS: France, Germany, UK, Italy, Netherlands, Spain, Sweden, Israel, Norway, Austria, Belgium, Denmark, Czech Republic, Finland, Switzerland, Slovakia, Ireland, Poland, S. Africa, Greece, Hungary, Saudi Arabia, United Arab Emira,  New Zealand, Australia, Japan, Mexico, Colombia, Brazil, S. East Asia, Korea, Canada,",
      "openfda": {
        "pma_number": [
          "P120010",
          "P180008",
          "P150001"
        ],
        "registration_number": [
          "1810909",
          "3010291427",
          "3013756811",
          "3016540876",
          "3012118659",
          "3038419886",
          "2032227",
          "1000134386",
          "3006371704",
          "3014353045",
          "3042027705",
          "3014498598",
          "3009171251",
          "3007981285",
          "2134850",
          "3011121740",
          "3004167884",
          "3007939342"
        ],
        "fei_number": [
          "1810909",
          "3010291427",
          "3013756811",
          "3016540876",
          "3012118659",
          "3038419886",
          "3003166194",
          "1000134386",
          "3010700165",
          "3014353045",
          "3006371704",
          "3042027705",
          "3006759904",
          "3014498598",
          "3003007876",
          "3007981285",
          "3004167884",
          "3007939342"
        ],
        "device_name": "Automated Insulin Dosing , Threshold Suspend",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}