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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Lot Codes / Batch Numbers
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.
Products Sold
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.
A medical device manufacturer is recalling X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US distribution). Model due to Loss of Operating Vacuum during use-It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may los. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, DC
Page updated: Jan 10, 2026