{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "218097",
      "product_res_number": "Z-1469-2026",
      "event_date_initiated": "2026-01-27",
      "event_date_posted": "2026-02-27",
      "recall_status": "Open, Classified",
      "res_event_number": "98276",
      "product_code": "PYX",
      "pma_numbers": [
        "P170011"
      ],
      "product_description": "Impella RP with SmartAssist. Product Code: 0046-0035.",
      "code_info": "Product Code: 0046-0035. UDI-DI: 00813502011869.",
      "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\n612-437-5734",
      "reason_for_recall": "Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Abiomed notified consignees on about 01/27/2026 via UPS delivery. Additionally, the Customer Letter was posted on Heartrecovery.com: https://www.heartrecovery.com/en-us/resources/downloads/field-safety-notification-impella-rp-differential-pressure-sensor. The notifications informed consignees were instructed clinicians that affected units can continue use and they should: \n\n1. Continue to monitor patient hemodynamics with approved diagnostic devices and continue to verify Impella positioning with imaging before clinical interventions. \n2. Refer to the P-level flow rates listed in the Instructions for Use (IFUs), as shown in Figure 1, and rely on these values rather than the AIC display.\n3. Trend pump metrics to monitor pump performance and to identify sudden change, noting that abrupt changes in the displayed flow rate need to be assessed both against the flow rate listed in the IFU and across temporal trends.  \n\nConsignees were instructed that product is NOT being removed from the field and does not need to be returned, patients should be assessed with approved diagnostic devices before clinical interventions, complete and return the provided business reply form (BRF) to Abiomed4437@sedgwick, forward the notification to anyone in the facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products) and if any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.",
      "product_quantity": "291 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide  and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.",
      "openfda": {
        "pma_number": [
          "P170011"
        ],
        "registration_number": [
          "3007904765",
          "1220648"
        ],
        "fei_number": [
          "3007904765",
          "1220648"
        ],
        "device_name": "Temporary Non-Roller Type Right Heart Support Blood Pump",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4360",
        "device_class": "3"
      }
    }
  ]
}