{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63316",
      "recalling_firm": "Greatbatch Medical",
      "address_1": "2300 Berkshire Ln N",
      "address_2": "N/A",
      "postal_code": "55441-4575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide distribution: CA only.",
      "recall_number": "Z-0132-2013",
      "product_description": "Biosense Webster MobiCath Bi-Directional Guiding Sheath.  Small Curve catalog no. D140010, Large Curve catalog no. D140011.  The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems.  The device features adjustable tip geometry through use of a rotating handle to deflect the catheter.  This catheter is assembled with a hemostasis valve and a sideport infusion line.      The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum.",
      "product_quantity": "9040",
      "reason_for_recall": "We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths.  We became aware of these interactions while investigating recent complaints regarding catheters \"self-advancing\" while being used in conjunction with the MobiCath Sheaths.",
      "recall_initiation_date": "20120924",
      "center_classification_date": "20121024",
      "termination_date": "20140515",
      "report_date": "20121031",
      "code_info": "Lot no.:  W2046680, W2046681, W2072907, W2078460, W2084872, W2098770, W2098771, W2102124, W2102128, W2102133, W2102134, W2108295, W2108296, W2108298, W2108299, W2108300, W2125688, W2125690, W2132584, W2132588, W2132590, W2138965, W2143146, W2143147, W2143149, W2143152, W2145645, W2145677, W2145680, W2145681, W2151287, W2151305, W2151308, W2156746, W2156748, W2156750, W2156751, W2162494, W2162496, W2162497, W2162498, W2162499, W2167985, W2167986, W2167987, W2167988, W2167990, W2172705, W2172706, W2172707, W2172708, W2172710, W2172712, W2177727, W2177728, W2177729, W2177730, W2177733, W2177734, W2184476, W2184483, W2184484, W2184485, W2184487, W2184489, W2190457, W2190461, W2190462, W2190464, W2190470, W2196349, W2196351, W2196352, W2196355, W2196359, W2196361, W2196363, W2211842, W2211844, W2211846, W2211849, W2211850, W2211851, W2211852, W2211853, W2213887, W2213890, W2213892, W2213896, W2213898, W2213901, W2213982, W2221631, W2222017, W2222020, W2222022, W2222024, W2222027, W2222030, W2224408, W2224412, W2224417, W2224421, W2224423, W2224433, W2229959, W2229960, W2229961, W2229963, W2229965, W2229973, W2229974, W2236558, W2236561, W2236588."
    }
  ]
}