{
  "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": "2026-08-12",
    "results": {
      "skip": 10100,
      "limit": 1,
      "total": 39756
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Fairfield",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92527",
      "recalling_firm": "Datascope Corp.",
      "address_1": "15 Law Dr Unit 1",
      "address_2": "N/A",
      "postal_code": "07004-3206",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Domestic distribution nationwide. International distribution worldwide.",
      "recall_number": "Z-2216-2023",
      "product_description": "YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta.    Product Description                                                                                        Part Number  YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT\tD684-00-0559-01  YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT\tD684-00-0559-02  YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT\tD684-00-0560-01  YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT\tD684-00-0560-02  YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT\tD684-00-0561-01  YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT\tD684-00-0561-02  PACKAGED INSERTION KIT - YAMATO PLUS-R 7.5 Fr. 30/35/40 cc IABs\tD886-00-0019-25",
      "product_quantity": "321,609 total kits",
      "reason_for_recall": "During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath.  Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.",
      "recall_initiation_date": "20230623",
      "center_classification_date": "20230721",
      "report_date": "20230802",
      "code_info": "Product Description                                                                                       UDI YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107585 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107592 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107608 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107615 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107622 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT 10607567107639"
    }
  ]
}