{
  "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": "Ongoing",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86847",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "300 Boston Scientific Way",
      "address_2": "N/A",
      "postal_code": "01752-1291",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "No US distribution. Foreign distribution to Latin America and EU.",
      "recall_number": "Z-0637-2021",
      "product_description": "EKOS Control System (CU) 4.0. UPN 600-40500      The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control.  A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter.",
      "product_quantity": "90 (OUS)",
      "reason_for_recall": "This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.",
      "recall_initiation_date": "20201103",
      "center_classification_date": "20201217",
      "report_date": "20201223",
      "code_info": "Serial numbers  CU4.0-01062  CU4.0-01063  CU4.0-01066  CU4.0-01068  CU4.0-01069  CU4.0-01070  CU4.0-01072  CU4.0-01073  CU4.0-01074  CU4.0-01076  CU4.0-01078  CU4.0-01079  CU4.0-01081  CU4.0-01083  CU4.0-01084  CU4.0-01086  CU4.0-01088  CU4.0-01089  CU4.0-01090  CU4.0-01091  CU4.0-01093  CU4.0-01094  CU4.0-01095  CU4.0-01096  CU4.0-01097  CU4.0-01100  CU4.0-01101  CU4.0-01102  CU4.0-01103  CU4.0-01104  CU4.0-01106  CU4.0-01107  CU4.0-01108  CU4.0-01110  CU4.0-01113  CU4.0-01114  CU4.0-01115  CU4.0-01116  CU4.0-01117  CU4.0-01119  CU4.0-01121  CU4.0-01123  CU4.0-01124  CU4.0-01126  CU4.0-01127  CU4.0-01128  CU4.0-01129  CU4.0-01130  CU4.0-01131  CU4.0-01132  CU4.0-01133  CU4.0-01134  CU4.0-01135  CU4.0-01138  CU4.0-01141  CU4.0-01142  CU4.0-01143  CU4.0-01144  CU4.0-01146  CU4.0-01147  CU4.0-01149  CU4.0-01151  CU4.0-01152  CU4.0-01153  CU4.0-01154  CU4.0-01157  CU4.0-01158  CU4.0-01159  CU4.0-01160  CU4.0-01161  CU4.0-01162  CU4.0-01163  CU4.0-01164  CU4.0-01165  CU4.0-01166  CU4.0-01167  CU4.0-01170  CU4.0-01173  CU4.0-01174  CU4.0-01175  CU4.0-01176  CU4.0-01177  CU4.0-01178  CU4.0-01179  CU4.0-01185  CU4.0-01186  CU4.0-01191  CU4.0-01195  CU4.0-01198  CU4.0-01203  CU4.0-01205  CU4.0-01215  CU4.0-01231  CU4.0-01233  CU4.0-01234  CU4.0-01237  CU4.0-01239  CU4.0-01245  CU4.0-01248  CU4.0-01251  CU4.0-01252  CU4.0-01255  CU4.0-01268  CU4.0-01289  CU4.0-01292  CU4.0-01299"
    }
  ]
}