Recall Z-0293-2018
Edwards Lifesciences, LLC · initiated July 21, 2017
Class I – dangerous or defective products that could cause serious health problems or death
Product
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.
Codes / lots: Lot Numbers: 60677653 60703356 60703356 60733369 60898859 60708907 60708907 60693311 60677343 60678033 60708907 60699067 60685057 60712982 60760615 60792834 60776987 60813952 60782083 60796436 60840392 60842807 60854965 60885861 60930443 60677270 60678035 60678040 60703355 60704423 60703355 60704423 60679106 60689105 60718006 60718007 60792838 60813951 60782088 60816613 60816614 60842808 60842810 60873492 60842809 60885862 60885863 60930444 60697333 60703357 60703357 60678007 60739663 60733367 60733366 60760822 60801453 60808313 60776988 60816615 60883652 60842811 60739661 60718977 60718978 60718979 60724851 60724852 60724853 60724854 60724855 60724856 60724857 60724858 60724859 60724860 60724861 60724862 60724863 60724864 60724865 60724866 60724867 60724868 60724869 60724870 60730280 60730282 60730283 60730284 60730285 60730286 60730287 60730288 60730318 60730289 60730319 60730320 60730321 60735835 60735836 60735789 60735790 60735791 60735792 60735793 60735794 60737235 60737236 60739823 60739824 60744633 60744634 60744636 60744637 60744638 60744635 60744823 60744824 60744825 60745017 60745016 60746726 60746727 60746728 60746729 60746730 60746731 60748826 60748827 60748828…
Reason for recall
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.
FDA-determined cause: Employee error
Action taken
Recall notification letters were sent to affected consignees via Fed-Ex on 7/21/2017.
Details
- Recall number
- Z-0293-2018
- Initiated
- July 21, 2017
- Posted by FDA
- January 10, 2018
- Terminated
- September 13, 2019
- Product code
- NPT – Aortic Valve, Prosthesis, Percutaneously Delivered
- Quantity
- 1730 units
- Distribution
- United States: All states with the exception of: Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota and Wyoming
- Recalling firm
- Edwards Lifesciences, LLC, Draper, UT