{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Reading",
      "state": "PA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85684",
      "recalling_firm": "Arrow International Inc",
      "address_1": "2400 Bernville Rd",
      "address_2": "N/A",
      "postal_code": "19605-9607",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.",
      "recall_number": "Z-2411-2020",
      "product_description": "Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E",
      "product_quantity": "2123 total",
      "reason_for_recall": "A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate.  A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for  System Error 3  and  High Baseline  presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.",
      "recall_initiation_date": "20200520",
      "center_classification_date": "20200626",
      "termination_date": "20230107",
      "report_date": "20200708",
      "code_info": "Serial Number Ranges:   AUTOCAT2 WAVE SPANISH IAP-0500E 150302W     150304W     150402W through 150403W     150408W     150514W     150826W     151014W     151107W     151110W     160425W through 160427W     160508W through 160510W     160518W  Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH IAP-0500E 160631W     160637W     160642W     160644W     160705W     160919W     170204W through 170206W     170221W     170308W     170328W     170928W     171116W     180333W     180840W     180939W     181054W     181056W through 181060W     190229W     190512W     190514W     190519W     190631W through 190633W"
    }
  ]
}