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.
This recall has been terminated (originally issued June 14, 2006).
- Recall Initiated
- February 14, 2006
- Posted
- June 14, 2006
- Terminated
- December 26, 2006
- Recall Number
- Z-1108-06
- Quantity
- Model number XD-CS1200-55 (US) 342 devices. Model number XR-CS1200-55 (OUS) 83 devices.
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
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.
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 / Code Info
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.
Root Cause
Other
Action Taken
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.