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SSUE: 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.

The Certitude Delivery System includes a balloon catheter that expands a compressed (crimped) THV, a loader that delivers the THV through the guiding tube, and extension tubing. During a procedure, the physician will first crimp the THV onto the balloon of the Certitude Delivery System. The Certitude Delivery System is then inserted into the body, usually during a transapical (inserted through small incision under left breast) or transaortic (inserted through small incision in the top right side of the chest) approach. The THV is then deployed through the guiding tube to the site of the native stenotic aortic valve, where it is expanded and fixed in place.

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