Recall Z-0293-2018 ยท NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Edwards Lifesciences, LLC
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) or transaortic (TAo) approach to transcatheter aortic valve replacement.
| Date | Jan 10, 2018 (initiated Jul 21, 2017) |
| Status | Terminated |
| Reason | A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient. |
| Root cause | Employee error |
| Action | Recall notification letters were sent to affected consignees via Fed-Ex on 7/21/2017. |
| Quantity | 1730 units |
| Distribution | United States: All states with the exception of: Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota and Wyoming |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.