Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow

From Drugs.com - January 11, 2018

Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow

Audience: Risk Manager, Cardiology, Surgery

Model/Item Numbers: 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A, 9600SDS20A, 9600SDS23A, 9600SDS26A, 9600SDS29A

[Posted 01/11/2018]

ISSUE: Edwards LifeSciences is recalling 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.

Such an embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. In dire situations, severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result.

BACKGROUND: The Edwards LifeSciences Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically used during a transcatheter aortic valve replacement.

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