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Z-1108-06

X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US distribution). Model number...

Medtronic, Inc. / initiated 2006-02-14 / Terminated
FDA source (opens on fda.gov)

Ev3, Inc began a recall of X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US distribution). Model number XR-CS1200-55 (for foreign distribution). 2.0mm... on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1108-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic, Inc.
Product
X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US distribution). Model number XR-CS1200-55 (for foreign distribution). 2.0mm. Sterilization with Ethylene Oxide Gas. ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA.
Product code
MCW Catheter, Peripheral, Atherectomy
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 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 in commerce
Model number XD-CS1200-55 (US) 342 devices. Model number XR-CS1200-55 (OUS) 83 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
Product codes and lots
Model number XD-CS1200-55 (for US distribution) lot numbers: 782706, 782707, 782708, 782708, 782708, 782718, 782724, 986901, 986902, 986904, 986908, 986909, 986910, 986911, 986912, 986915, 986916, 986918, 986919, 986921, 986922, 986922, 986922, 986922, 986922, 986925, 986932, 986934, 1130582, 1156888, 1156888, 1156888, 1212539, 1212540, 1212543, 1215499, 1215500, 1215506, 1215511, 1215511, 1215511, 1215514, 1242336, 1328479, 1328597, 1336891, 1337003.   Model number for XR-CS1200-55 (OUS distribution) lot numbers: 782873, 782875, 782876, 782877, 782878,  782879, 987127, 987128, 987129, 987130, 987131,  987132, 1302736, 1327016, 1344586, 1344591, 1344595,  1344614, 1344624, 1344626, 1344627, 1344633, 1346625,  1346626, 1346651, 1346676, 1346677, 1346678, 1364066,  1364075, 1364081, 1364082, 1364090, 1364099, 1364118,  1364170, 1364179, 1364186, 1364200, 1364226, 1364255,  1364283.