{
  "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": "Terminated",
      "city": "Temecula",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73243",
      "recalling_firm": "Abbott Vascular",
      "address_1": "26531 Ynez Rd",
      "address_2": "N/A",
      "postal_code": "92591-4630",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina Luxembourg Australia Malaysia Austria Mexico Belgium Netherlands Brazil New Zealand Canada Norway Colombia Philippines Corrientes Poland Czech Republic Portugal Denmark Egypt Romania Finland Saudi Arabia France Slovenia Germany Spain Greece Sweden Hong Kong Switzerland Hungary Thailand Indonesia Turkey Israel United Arab Emirates Italy United Kingdom Kuwait and Vietnam.",
      "recall_number": "Z-0911-2016",
      "product_description": "MitraClip Clip Delivery System, product number MSK0101. The MitraClip System  contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921.    The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.",
      "product_quantity": "7,600 units total (2,300 units in US)",
      "reason_for_recall": "Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to a mandrel fracture.",
      "recall_initiation_date": "20160204",
      "center_classification_date": "20160307",
      "termination_date": "20160512",
      "report_date": "20160316",
      "code_info": "Lot number   50811U1  50811U2  50812U1  50813U1  50814U1  50826U1  50826U2  50827U1  50908U1  50908U2  50909U1  50910U1  50910U2  50911U1  50924U1  50925U1  50928U1  50929U1  51010U1  51012U1  51012U2  51013U1  51014U1  51014U2  51026U1  51027U3  51028U1  51028U2  51029U1  51030U1  51105U1  51106U1  51109U1  51109U2  51110U1  51110U2  51117U1  51203U1  51204U1  51205U1  51207U1"
    }
  ]
}