Edwards Lifesciences product recalled over mold contamination

Recall date

July 21, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Edwards Lifesciences, LLC recalls Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usa…

Recall number

Z-0293-2018

FDA classification

Class I

Brand / firm

Edwards Lifesciences, LLC

Sold / distributed

United States: All states with the exception of: Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota and Wyoming

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.