FDA Posts Outdated Alert for Sapien 3 Transapical Delivery System

The US Food and Drug Administration (FDA) posted a safety alert to its MedWatch website today alerting patients and healthcare professionals to a 6-month-old recall affecting the transapical/transaortic delivery system used for Sapien 3 (Edwards Lifesciences). A spokesperson for the manufacturer, however, clarified that this issue has already been resolved without incident.

The FDA’s note describes an issue with the Certitude Delivery System due to a “molding overflow defect in the button valve,” located within the loader. According to the FDA, 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.”

Contacted by TCTMD, a company spokesperson clarified that this is an “old recall” resolved more than 6 months ago, and expressed surprise at the FDA’s timing.

“All potentially affected inventory was swapped out without disruption, and there were no patient safety issues and no customer complaints,” the spokesperson noted. Of note, Certitude is the Sapien 3 transapical delivery system and so is rarely used. Transapical procedures represent a “very low, single-digit percentage of TAVR procedures,” she said