{
  "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-2410-2020",
      "product_description": "Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500",
      "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 IAP-0500 140861W through 140865W     140910W through 140913W     150101W     150103W through 150105W     150108W through 150109W     150114W     150119W     150202W through 150219W     150303W  Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 150306W     150310W     150404W through 150406W     150410W     150501W through 150506W     150515W     150606W through 150607W     150612W through 150622W     150701W     150706W     150708W through 150712W     150717W through 150719W     150803W through 150820W     150822W through 150823W     150825W     150913W through 150918W     150924W     150940W     151001W through 151008W     151017W through 151018W     151020W     151028W     151109W     151112W     151115W through 151120W     160104W     160110W through 160111W     160121W     160123W through 160125W     160127W through 160130W     160210W     160212W     160215W     160218W     160220W     160301W through 160304W     160307W through 160311W     160315W     160324W     160328W through 160330W     160332W through 160340W     160411W  Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 160413W through 160417W     160423W through 160424W     160428W     160501W through 160502W     160504W through 160507W     160520W through 160524W     160526W through 160528W     160601W through 160604W     160606W through 160613W     160615W through 160617W     160620W through 160629W     160632W through 160633W     160701W through 160702W     160704W     160706W through 160713W     160716W through 160717W     160719W     160721W through 160725W     160727W     160734W through 160742W     160744W through 160745W     160801W through 160803W     160805W through 160823W     160825W through 160827W     160829W through 160830W     160901W through 160917W     160920W through 160945W     170201W through 170203W     170207W through 170208W     170211W through 170220W     170222W through 170230W     170301W     170303W through 170307W     170309W through 170327W     170329W through 170330W     170606W through 170610W     170921W through 170927W     170929W through 170930W     170941W through 170950W     171101W through 171104W     171118W     171202W through 171205W  Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 180111W through 180119W     180302W through 180308W     180310W     180331W through 180332W     180334W through 180340W     180501W through 180510W     180531W through 180540W     180611W through 180620W     180721W through 180730W     180751W through 180760W     180831W through 180839W     180932W through 180938W     180940W through 180941W     181051W through 181053W     181055W     190111W through 190118W     190222W     190227W through 190228W     190230W     190321W through 190330W     190511W     190513W     190515W through 190518W     190520W through 190530W     190621W through 190630W     190634W through 190640W     190849W through 190860W     191043W through 191046W     191048W     200213W through 200236W"
    }
  ]
}