{
  "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": "63676",
      "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": "Worldwide Distribution-USA including the states of AL, AK, AZ, ALR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KY, MD, MA, MI, MN, MO, NE, NV,NM, NJ, NH, NY, NC, OH, OK OR, PA, RI,SC,SD, TN, TX, UT,VT, VA, WA, and WI, and the countries of AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HUNGARY, IRELAND, ISRAEL, ITALY, THE NETHERLAND, NORWAY, SWEDEN, AUSTRALIA, and CANADA",
      "recall_number": "Z-0611-2013",
      "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": "10,201 units",
      "reason_for_recall": "Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool.  The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen).",
      "recall_initiation_date": "20121112",
      "center_classification_date": "20121222",
      "termination_date": "20140515",
      "report_date": "20130102",
      "code_info": "LOT:  R1701247 , R1713591 , W2046680 , W2046681 , W2072907 , W2078460 , W2084872 , W2098771 , W2102124 , W2102133 , W2102134 , W2108295 , W2108296 , W2108298 , W2108299 , W2125688 , W2125690 , W2132584 , W2132588 , W2132590 , W2138965 , W2143147 , W2143149 , W2143152 , W2145645 , W2145677 , W2145680 , W2145681 , W2151287 , W2151305 , W2151308 , W2156746 , W2156748 , W2156750 , W2156751 , W2162496 , W2162497 , W2162498 , W2162499 , W2167986 , W2167987 , W2167988 , W2167990 , W2172705 , W2172706 , W2172707 , W2172708 , W2172710 , W2172712 , W2177727 , W2177728 , W2177733 , W2177734 , W2184476 , W2184483 , W2184484 , W2184487 , W2190457 , W2190461 , W2190464 , W2190470 , W2196349 , W2196351 , W2196352 , W2196355 , W2196359 , W2196361 , W2196363 , W2211842 , W2211844 , W2211846 , W2211849 , W2211852 , W2211853 , W2213887 , W2229974 , W2236588."
    }
  ]
}