Recall Z-3077-2017 ยท DXE Catheter, Embolectomy
Edwards Lifesciences, LLC
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are designed to facilitate clots too resistant to be removed by an elastomeric bal
| Date | Jul 6, 2017 |
| Status | Terminated |
| Reason | The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm. |
| Root cause | Packaging |
| Action | Recall notification letters were sent to affected customers on 7/6/2017. The recall notice included a response form and instructed consignee to return any unused devices.. |
| Quantity | 200 units |
| Distribution | Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901625 | FOGARTY ARTERIAL EMBOLECTOMY II CATHETER Baxter Healthcare Corp, Jul 6, 1990 |