Ev3, Inc: 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 number

Z-1107-06

Recalling firm

Ev3, Inc

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.

Status

Terminated

Initiated

2006-02-14

Posted

2006-06-14

Terminated

2006-12-26

Reason

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.

Root cause

Other

Action

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.

Quantity

Model number XD-CS1150-45 (US) 534 devices. Model number XR-CS1150-45 (OUS) 504 devices.

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

Lot, serial or model codes

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.

510(k) numbers

["K021096"]

PMA numbers

not on file

Product code

MCW

Firm FEI

2183870

Firm city

Plymouth

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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