Class 3 Device Recall XSizer Thrombectomy Catheter System

• Date Initiated by Firm: February 14, 2006
• Date Posted: June 14, 2006
• Recall Status: Terminated on December 26, 2006
• Recall Number: Z-1107-06
• Recall Event ID: 34708
• 510(K)Number: K021096
• Product Classification: Thrombectomy Catheter System - Product Code MCW
• 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Ev3, Inc; 4600 Nathan Ln N; Plymouth MN 55442-2890
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MCW and Original Applicant = EV3 CORPORATION