Recall Z-1108-06 ยท MCW Catheter, Peripheral, Atherectomy
Ev3, Inc
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.
| Date | Jun 14, 2006 (initiated Feb 14, 2006) |
| Status | Terminated |
| 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-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, German |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021096 | X-SIZER CATHETER SYSTEM Ev3 Corporation, Sep 8, 2004 |