{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "220257",
      "product_res_number": "Z-2457-2026",
      "event_date_initiated": "2026-05-18",
      "event_date_posted": "2026-06-18",
      "recall_status": "Open, Classified",
      "res_event_number": "98946",
      "product_code": "OZD",
      "pma_numbers": [
        "P140003"
      ],
      "product_description": "Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.",
      "code_info": "GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).",
      "firm_fei_number": "1220648",
      "recalling_firm": "Abiomed, Inc.",
      "address_1": "22 Cherry Hill Dr",
      "city": "Danvers",
      "state": "MA",
      "postal_code": "01923-2575",
      "additional_info_contact": "Morgaine Johnson\n978-646-1400",
      "reason_for_recall": "Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Johnson & Johnson MedTech/Abiomed Issued an URGETN MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 05/18/2026 via UPS 1-day air delivery.  The notice explained the reason for notification and potential patient impact Consignees were instructed to review all Impella CP Sets within inventory and quarantine affected units on hand, return all affected units using the provided return shipment label from Sedgwick, and complete and return the provided business response form. Upon receipt of returned product and completed BRF, Abiomed will provide a copy of a credit memo for the amount returned.  Consignees were also instructed to forward the notification to anyone in each facility that needs to be informed and to post a copy of the notification in a visible area for awareness. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.",
      "product_quantity": "10 units",
      "distribution_pattern": "US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan",
      "openfda": {
        "pma_number": [
          "P140003"
        ],
        "registration_number": [
          "3007904765",
          "2528981",
          "1220648"
        ],
        "fei_number": [
          "3007904765",
          "2528981",
          "1220648"
        ],
        "device_name": "Temporary Non-Roller Type Left Heart Support Blood Pump",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}