Devices

Device Recall XSizer Thrombectomy Catheter System

  • Modelo / Serial
    Model number XD-CS1150-45 (for US distribution), lot numbers: 782344, 782345, 782366, 782379, 782386, 782389,  782403, 782404, 782406, 782407, 782412, 782421, 782428,  782429, 782430, 782436, 782438, 782439, 782441, 782445,  782526, 986604, 986604, 986604, 986605, 986609, 986620,  986626, 986640, 986641, 986642, 986645, 986656, 986659,  1174394, 1174395, 1212529, 1229730, 1231296, 1234273,  1240986, 1241067, 1271238, 1272506, 1280664, 1280952,  1281088, 1282693, 1289590, 1289978, 1293902, 1295372,  1300605, 1302005, 1303572, 1308536, 1310238, 1362165.   Model number XR-CS1150-45 (for OUS distribution), lot numbers: 782773, 782777, 782787, 782788, 782790, 782791,  782795, 782796, 782797, 782798, 782800, 782801, 782804,  782808, 782811, 782812, 782816, 782818, 782822, 782848,  987054, 987055, 987056, 987058, 987059, 987062, 987063,  987064, 987065, 987066, 987067, 987070, 987070, 987070,  987071, 987073, 987076, 987078, 1057871, 1077841, 1077842, 1077843, 1077844, 1077846, 1077847, 1077848,  1077854, 1077856, 1077859, 1077862, 1095087, 1095089,  1296437, 1296552, 1313297, 1313502, 1313543, 1313562,  1313611, 1313645, 1314989, 1314991, 1314994, 1315002, 1315042, 1315058, 1315113, 1315140, 1315183, 1315211,  1315245, 1315292, 1315294, 1315313, 1315328, 1315365,  1315378, 1315383, 1315623, 1315624, 1315625, 1315626,  1315632, 1315633, 1315636, 1315639, 1315640, 1315644,  1315646, 1317128, 1317133, 1317134, 1317135, 1317144,  1317301, 1326969, 1326969, 1326969, 1326970, 1326972,  1326973, 1326974, 1326977, 1326982, 1326983, 1326998,  1326999, 1327006, 1327008, 1327011, 1327546, 1342794,  1342852, 1342874, 1342882, 1342888, 1342957, 1342980,  1343007, 1343019, 1343036, 1343045, 1343094, 1343108,  1343125, 1343136, 1343266, 1343273, 1343292, 1343314,  1363701, 1363712, 1363725, 1363742, 1363791, 1363827,  1363850, 1363974, 1363976, 1364006, 1364034, 1364049.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    World wide-AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. OUS to: Argentina, Australia, Austria, Brazil, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Jordan, Mexico, Netherlands, Norway, Pakistan, Portugal, Saudi Arabi, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom
  • Descripción del producto
    X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US distribution). Model number XR-CS1150-45 (for foreign distribution). 1.5mm. Sterilization with Ethylene Oxide Gas. ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA.
  • Manufacturer
    Ev3, Inc
  • 1 Event

Fabricante

Ev3, Inc
  • Dirección del fabricante
    Ev3, Inc, 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

Device Recall XSizer Thrombectomy Catheter System
  • Modelo / Serial
    Model number XD-CS1200-55 (for US distribution) lot numbers: 782706, 782707, 782708, 782708, 782708, 782718, 782724, 986901, 986902, 986904, 986908, 986909, 986910, 986911, 986912, 986915, 986916, 986918, 986919, 986921, 986922, 986922, 986922, 986922, 986922, 986925, 986932, 986934, 1130582, 1156888, 1156888, 1156888, 1212539, 1212540, 1212543, 1215499, 1215500, 1215506, 1215511, 1215511, 1215511, 1215514, 1242336, 1328479, 1328597, 1336891, 1337003.   Model number for XR-CS1200-55 (OUS distribution) lot numbers: 782873, 782875, 782876, 782877, 782878,  782879, 987127, 987128, 987129, 987130, 987131,  987132, 1302736, 1327016, 1344586, 1344591, 1344595,  1344614, 1344624, 1344626, 1344627, 1344633, 1346625,  1346626, 1346651, 1346676, 1346677, 1346678, 1364066,  1364075, 1364081, 1364082, 1364090, 1364099, 1364118,  1364170, 1364179, 1364186, 1364200, 1364226, 1364255,  1364283.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    World wide-AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. OUS to: Argentina, Australia, Austria, Brazil, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Jordan, Mexico, Netherlands, Norway, Pakistan, Portugal, Saudi Arabi, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom
  • Descripción del producto
    X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US distribution). Model number XR-CS1200-55 (for foreign distribution). 2.0mm. Sterilization with Ethylene Oxide Gas. ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA.
  • Manufacturer
    Ev3, Inc