Devices

Device Recall XSizer Thrombectomy Catheter System

  • Model / 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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    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

Manufacturer

Ev3, Inc
  • Manufacturer Address
    Ev3, Inc, 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall XSizer Thrombectomy Catheter System
  • Model / 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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    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