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.
Hazard
Loss of Operating Vacuum during use-It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may lose operating vacuum prematurely due to a system leak within the Control Module. This failure can lead to the inaility to complete the procedure of thrombus removal and the necessity to remove the device prior to achieving a satisfactory result.
What You Should Do
A medical Device Recall Letter dated 02/13/06 was sent to hospitals along the affected device lot numbers the hospital should have received on a Device Reconciliation Form. ev3 is asking for affected devices to be returned. Returned devices will be replaced at no cost.
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Products
- UPC
- 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.
Units Affected
Model number XD-CS1150-45 (US) 534 devices. Model number XR-CS1150-45 (OUS) 504 devices.