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Medical Device Recalls
Class 3 Recall
X-Sizer Thrombectomy Catheter System
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Date Recall
Initiated |
February 14, 2006
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| Date Posted |
June 14, 2006
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| Recall Number |
Z-1107-06
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| 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.
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| 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.
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Recalling Firm/
Manufacturer |
Ev3, Inc
4600 Nathan Ln N
Plymouth
, Minnesota
55442-2890
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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.
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| 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.
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| Quantity in Commerce |
Model number XD-CS1150-45 (US) 534 devices. Model number XR-CS1150-45 (OUS) 504 devices.
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| 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
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