{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Wayne",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97450",
      "recalling_firm": "Maquet Cardiovascular, LLC",
      "address_1": "45 Barbour Pond Dr",
      "address_2": "N/A",
      "postal_code": "07470-2094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.",
      "recall_number": "Z-2587-2025",
      "product_description": "Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.",
      "product_quantity": "28,331 units (16,615 US, 11,716 OUS)",
      "reason_for_recall": "Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.",
      "recall_initiation_date": "20250815",
      "center_classification_date": "20250918",
      "report_date": "20250924",
      "code_info": "Model No. HSK-3038; UDI: 00607567700314¿; Serial No. 3000377764, 3000378278, 3000379222, 3000379987, 3000383569, 3000388598, 3000390377, 3000394076, 3000396875, 3000398149, 3000400694, 3000402932, 3000403566, 3000404026, 3000404996, 3000405699, 3000407693, 3000409172, 3000409619, 3000410091, 3000410583, 3000412000, 3000412963, 3000415599, 3000416141, 3000417121, 3000417711, 3000418572, 3000418772, 3000419866, 3000420311, 3000422320, 3000422757, 3000423694, 3000424888, 3000425725, 3000428927, 3000429846, 3000431259, 3000431934, 3000434091, 3000434862, 3000435356, 3000436032, 3000436446, 3000440202, 3000441040, 3000441162, 3000442134, 3000443538, 3000443910, 3000444136, 3000446374, 3000447343, 3000448483, 3000449214, 3000449897, 3000450561, 3000451914, 3000452532, 3000453432, 3000453804, 3000455728, 3000456346, 3000457969, 3000458434, 3000459087, 3000459889, 3000460034, 3000461587, 3000464463, 3000465229, 3000465676, 3000465679, 3000466111, 3000466878, 3000467559, 3000470706, 3000471492, 3000473348, 3000473350, 3000475032, 3000475033, 3000476158, 3000476611, 3000477574, 3000478410, 3000479294, 3000479465, 3000481661, 3000484284, 3000485833, 3000488966, 3000377764, 3000378278, 3000379222, 3000379987, 3000388598, 3000391049, 3000394076, 3000396875, 3000398149, 3000400694, 3000403566, 3000404026, 3000404996, 3000405699, 3000409172, 3000409619, 3000410091, 3000412000, 3000412963, 3000415599, 3000417121, 3000417752, 3000418572, 3000419866, 3000420311, 3000422320, 3000423694, 3000424888, 3000425725, 3000428927, 3000431259, 3000431934, 3000434091, 3000434862, 3000435356, 3000436032, 3000436109, 3000436446, 3000437664, 3000440202, 3000440757, 3000441162, 3000442134, 3000442635, 3000443538, 3000443910, 3000444136, 3000446374, 3000447140, 3000447343, 3000448483, 3000449214, 3000449897, 3000450292, 3000451914, 3000452532, 3000452651, 3000453432, 3000453804, 3000455728, 3000456197, 3000456346, 3000457780, 3000457969, 3000458434, 3000459889, 3000460034, 3000461587, 3000464463, 3000465228, 3000465229, 3000465676, 3000465679, 3000466111, 3000466878, 3000467559, 3000470706, 3000471492, 3000473348, 3000475032, 3000475033, 3000476158, 3000477574, 3000478410, 3000479294, 3000479465, 3000481661, 3000484284, 3000484896, 3000488349, 3000488742, 3000488966."
    }
  ]
}