{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Quincy",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86466",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "500 Commander Shea Blvd",
      "address_2": "N/A",
      "postal_code": "02171-1518",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the states of (1) MD (2) NY (3) MI (4) CT (5) SD (6) GA.",
      "recall_number": "Z-0181-2021",
      "product_description": "Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021  Material Number (UPN) # H7493932800350  UDI # 08714729984542  Lot #25754545; 25852104; 2582106; 25856700  Product Usage:  intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.",
      "product_quantity": "41 devices",
      "reason_for_recall": "Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date.     The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter.    All recalled devices should be returned to Boston Scientific.",
      "recall_initiation_date": "20200824",
      "center_classification_date": "20201022",
      "termination_date": "20240405",
      "report_date": "20201028",
      "code_info": "Opticross 35 15 MHz Peripheral Imaging Catheter   8F (2.74 mm) X 105 cm  Expiration Date June 8th 2021 - July 22nd 2021  Material Number (UPN) # H7493932800350  UDI # 08714729984542  Lot #25754545; 25852104; 2582106; 25856700"
    }
  ]
}