{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "204906",
      "product_res_number": "Z-0636-2024",
      "event_date_initiated": "2023-12-06",
      "event_date_posted": "2024-01-04",
      "recall_status": "Open, Classified",
      "res_event_number": "93581",
      "product_code": "PYX",
      "pma_numbers": [
        "P170011",
        "P140003"
      ],
      "product_description": "Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.",
      "code_info": "UDI-DI 00813502011647\nSoftware version 1.1 - 3.17.1",
      "firm_fei_number": "1220648",
      "recalling_firm": "Abiomed, Inc.",
      "address_1": "24 Cherry Hill Dr",
      "city": "Danvers",
      "state": "MA",
      "postal_code": "01923-2575",
      "additional_info_contact": "978-646-1400",
      "reason_for_recall": "The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness:\n\nNotifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature",
      "root_cause_description": "No Marketing Application",
      "action": "On December 6, 2023, the firm notified affected customers via a Correction Letter delivered by the ImpellaConnect.com portal.\n\nCustomers were informed that the affected features were disabled from the web-based portal.\n\nIf you have questions or concerns regarding this notice, please contact ImpellaConnect@abiomed.com and/or your local clinical field staff.",
      "product_quantity": "n/a - no physical product",
      "distribution_pattern": "Domestic distribution nationwide.",
      "openfda": {
        "pma_number": [
          "P170011"
        ],
        "registration_number": [
          "1220648",
          "3007904765"
        ],
        "fei_number": [
          "1220648",
          "3007904765"
        ],
        "device_name": "Temporary Non-Roller Type Right Heart Support Blood Pump",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4360",
        "device_class": "3"
      }
    }
  ]
}