The United States Food and Drug Administration (FDA) has posted a safety alert to the public and healthcare professionals regarding Certitude Delivery Systems, manufactured by Edwards LifeSciences. The Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve, typically used during a transcatheter aortic valve replacement.
The affected devices are identified as the following:-
The manufacturer is recalling its Certitude Delivery System due to a molding overflow defect in the button valve within the loader.
According to the manufacturer, 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.
The manufacturer sent a "Recall Notification Letter" to inform affected users of the device's risks and directed them to check all inventory for the affected products. Product recall is on-going
For details, please refer to the FDA website:
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm592086.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 January 2018