{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "218584",
      "product_res_number": "Z-1591-2026",
      "event_date_initiated": "2026-02-16",
      "event_date_posted": "2026-03-27",
      "recall_status": "Open, Classified",
      "res_event_number": "98393",
      "product_code": "OZD",
      "pma_numbers": [
        "P140003"
      ],
      "product_description": "Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: \n\n1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. \n\n2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. \n\n3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.\n\n4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. \n\n5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. \n\n6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. \n\n7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. \n\n8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. \n\n9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.",
      "code_info": "All products below with software version 8.2.2 through 8.5 are affected.\n\n1. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC2035, IC9416. \n\n2. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC1677, IC3049, IC3099, IC3102, IC4358, IC4329, IC5774, IC5757, IC6580, IC6581.\n\n3. Product Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC2023, IC1910, IC2704, IC3325, IC3312.\n\n4. Product Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC1140.\n\n5. Product Code: 0042-0010-EU; GTIN: 00813502010961; Serial Numbers: IC5403, IC5404, IC5635, IC5636, IC5666, IC5667, IC5801, IC5904, IC5918, IC5921, IC6421, IC6422, IC8683. \n\n6. Product Code: 0042-0010-UK; GTIN: 00813502010978; Serial Numbers: IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC11440. \n\n7. Product Code: 0042-0040-CA; GTIN: 00813502012958; Serial Numbers: IC10306, IC10312, IC12604, IC12891, IC12895, IC12892, IC12605, IC12894. \n\n8. Product Code: 0042-0040-EU; GTIN: 00813502012217; Serial Numbers: IC9014, IC9022, IC9429, IC10408, IC10425. \n\n9. Product Code: 0042-0040-AU; GTIN: 00813502012972; Serial Numbers: IC10163, IC10387, IC11546, IC11566, IC11490, IC11544, IC12008, IC12054, IC11472, IC12151.",
      "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": "Potential that the \"Purge System Blocked\"  alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.",
      "root_cause_description": "Software design",
      "action": "Abiomed notified international consignees on about 02/16/2026 via emailed CRITICAL PRODUCT CORRECTION letter.  Consignees were instructed to cease use of the Automated Impella Controller (AIC) with an Impella 5.5 S1 (product code 0550-0007) unless AIC software is updated to v10.1 or above, identify current software in the lower left corner of the initial AIC display screen, contact your local Abiomed representative to schedule your software update, review and complete the customer response form provided and post this notification in a visible area for awareness. Consignees were also instructed to forward this notification to anyone within the facility that should be aware and forward the notification to consignees if further distributed.",
      "product_quantity": "62 units",
      "distribution_pattern": "International distribution in the country of Australia, Canada, France, Germany, Kuwait.",
      "openfda": {
        "pma_number": [
          "P140003"
        ],
        "registration_number": [
          "2528981",
          "3007904765",
          "1220648"
        ],
        "fei_number": [
          "2528981",
          "3007904765",
          "1220648"
        ],
        "device_name": "Temporary Non-Roller Type Left Heart Support Blood Pump",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}