{
  "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-2416-2020",
      "product_description": "Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700",
      "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 AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 150312F through 150313F     150315F     150318F     150321F     150324F through 150326F     161101F through 161110F     161112F through 161120F     161201F through 161210F     170101F through 170120F     170701F through 170710F     170801F through 170810F     170901F through 170920F     170931F through 170940F     171002F through 171010F     171031F through 171036F     171126F through 171130F     180101F through 180105F  Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 180121F through 180125F     180201F through 180210F     180311F through 180330F     180401F through 180410F     180421F through 180425F     180431F through 180440F     180511F through 180520F     180601F through 180605F     180701F through 180710F     180801F through 180810F     180821F through 180825F     180922F through 180931F     181041F through 181050F     181101F through 181110F     181201F through 181210F     190101F through 190110F     190131F through 190135F     190201F through 190210F     190231F through 190250F     190301F through 190303F     190305F through 190320F     190331F through 190335F     190401F through 190410F     190421F through 190430F     190441F through 190450F     190501F through 190510F     190541F through 190550F     190601F through 190620F     190641F through 190645F     190713F through 190730F     190801F through 190812F     190826F through 190834F     190901F through 190912F     190925F through 190930F     191013F through 191018F     191037F through 191042F     191049F through 191054F     191113F through 191136F     191201F through 191212F     200101F through 200106F     200137F through 200148F     200201F through 200212F  Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 200301F through 200306F     200325F through 200326F     200328F through 200339F     200341F through 200348F"
    }
  ]
}