X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US distribution). Model number XR-CS1150-45 (f
FDA device recall Z-1107-06 · posted 2006-06-14 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 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: Argen
- Date initiated
- 2006-02-14
- Date posted
- 2006-06-14
- Date terminated
- 2006-12-26
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| X-SIZER CATHETER SYSTEM (K021096) | Ev3 Corporation | 2004-09-08 |