{
  "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": "Saluggia",
      "state": "N/A",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86161",
      "recalling_firm": "Sorin Group Italia S.r.l.",
      "address_1": "Via Crescentino Sn",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the states of CA, FL, ID, ME, MN, MO, MS, NC, SD, OH, OR, PA, SD, TN, TX, VA, WA, WI and the countries of Canada, Japan, Germany, Netherland, Switzerland, Sweden, UK, Spain, Italy, France, Belgium, Finland, Greece, Slovenia, Malta, Poland, Romania, Croatia, Hungary, Serbia, Australia, Israel, Georgia, Iran, Kuwait, Oman, Quatar, Singapore, Thailand, Taiwan, Russia, South Africa.",
      "recall_number": "Z-2987-2020",
      "product_description": "Perceval Single Use Accessory Kit, Size M, REF:  ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.",
      "product_quantity": "225 kits",
      "reason_for_recall": "LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing  the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.",
      "recall_initiation_date": "20200729",
      "center_classification_date": "20200918",
      "termination_date": "20210517",
      "report_date": "20200930",
      "code_info": "Kit Lots:  2002200199, 2002200198, 2002130162, 2002130160, 2002060224 20013003412002130161"
    }
  ]
}