> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Edwards Recalls Certitude Delivery System
- URL: https://www.fdaweb.com/edwards-recalls-certitude-delivery-system/
- Published: 2018-01-11T12:00:00.000Z
- Updated: 2026-09-14T23:12:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140480

Edwards LifeSciences has recalled its Certitude Delivery System due to a molding overflow defect in the button valve within the loader. “The overflow material could detach during placement of the delivery system and potentially embolize into the patient,” a [recall notic](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm592086.htm?ref=fdaweb.com)e says. The device is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV) during a transcatheter aortic valve replacement. It includes a balloon catheter that expands a compressed (crimped) THV, a loader that delivers the THV through the guiding tube, and extension tubing.