Recall Z-1342-2016 ยท DXE Catheter, Embolectomy
Boston Scientific Corporation
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
| Date | Apr 18, 2016 (initiated Mar 22, 2016) |
| Status | Terminated |
| Reason | Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient. |
| Root cause | Process control |
| Action | The firm,Boston Scientific, "Urgent Medical Device Recall Notice - Immediate Action Required" letter dated 3/22/2016. The letter was addressed to Material Manger / Field Action Contact. The letter described the problem and the product involved in the recall and actions to be taken. The customers were instructed to immediately cease further distribution or use of the product and complete and return the Reply Verification Tracking Form via email: BSCFieldActionCenter@bsci.com or fax to: BSC Field Action Center at 1-866-213-1806. Distributors should notify their customers of the recall and inf |
| Quantity | 21,155 units |
| Distribution | Worldwide Distribution - US (nationwide) including DC & VI except DE, ID, SD, and WY and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Chile, Croatia, Cyprus, Ecuador, France, Germany, Great Britain, Hungary, Italy, Japan, Jordan, Korea, Malaysia, Mauritius, Mexico, Netherlands, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101354 | FETCH 2 ASPIRATION CATHETER MODEL 109400-001 Medrad Interventional/Possis, Jan 21, 2011 |