​Edwards—Certitude Delivery Systems: Certitude Loader Molding Overflow Defect May Detach during Advancement and Embolize into the Patient

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In a July 21, 2017, Urgent Product Recall letter submitted by ECRI Institute member hospitals, Edwards states that a component in the Certitude Loader of the above delivery systems may have a molding overflow defect that may detach during advancement of the delivery system and potentially embolize from the loader into the patient. Edwards also states that, while a low incidence rate of this defect has been observed during the manufacturing process, the potential impact could be significant. If the overflow material were to embolize once the device is introduced into the patient, a potential exists for blood flow obstruction and serious injury and/or necessitating surgical extraction of the overflow material from the patient. Edwards further states that it has received no reports of this problem occurring during clinical use. Any patient harm related to this defect would present during the delivery procedure. Therefore, if a procedure has been completed successfully, there is no further risk to the patient. Edwards states that the Certitude Delivery System is used only during a transapical (TA) or transaortic (TAo) approach...