{
  "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-2408-2020",
      "product_description": "Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400",
      "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:  Arrow AutoCAT 2 Intra-Aortic Balloon Pump   AUTOCAT 2 IAP-0400 140868V     140901V through 140909V     140914V through 140920V     150102V     150106V through 150107V     150110V through 150113V     150115V through 150116V     150220V     150401V     150407V     150409V     150507V through 150513V     150601V through 150605V     150608V through 150611V     150625V     150702V through 150705V     150707V     150720V     150801V through 150802V     150821V     150824V     150827V through 150830V     150901V through 150906V     150908V through 150912V     150919V through 150923V     150925V through 150939V     151009V through 151013V     151015V through 151016V     151019V     151021V through 151027V     151029V     151102V through 151103V     151105V     151108V     151111V     151113V     151201V through 151208V     151210V through 151212V     151214V through 151218V  Arrow AutoCAT 2 Intra-Aortic Balloon Pump  AUTOCAT 2 IAP-0400 151220V     160101V through 160103V     160105V through 160109V     160112V through 160118V     160120V     160122V     160126V     160201V through 160209V     160211V     160213V through 160214V     160216V through 160217V     160219V     160312V through 160314V     160316V through 160323V     160325V through 160327V     160331V     160401V through 160410V     160412V     160418V through 160422V     160519V     160525V     160529V through 160530V     160605V     160614V     160618V     160630V     160638V through 160639V     160645V     160703V     160718V     160720V     160726V     160728V through 160730V     170101V through 170110V     170401V through 170410V     170501V through 170520V     170601V through 170625V     170811V through 170830V     171021V through 171030V     171037V through 171046V     171106V through 171115V     180131V through 180150V  Arrow AutoCAT 2  Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 180211V through 180230V     180411V through 180420V     180441V through 180450V     180521V through 180530V     180621V through 180630V     180711V through 180720V     180741V through 180750V     180811V through 180820V     181011V through 181040V     181111V through 181130V     190121V through 190130V     190141V through 190150V     190211V through 190220V     190411V through 190420V     190431V through 190440V     190531V through 190540V     190701V through 190712V     190737V through 190748V     190813V through 190824V     190837V through 190848V     190913V through 190924V     190937V through 190948V     191001V through 191012V     191025V through 191036V     191101V through 191112V     191137V through 191148V     200113V through 200136V     200314V through 200324V"
    }
  ]
}