SILVER SPRING, MD — Edwards Lifesciences has recalled its Certitude Delivery System because of a mold overflow defect in the button valve within the loader that may obstruct blood flow, the US Food and Drug Administration (FDA) said.
This is a Class I recall, meaning the problem may cause serious harm or death.
The Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve, typically used during transcatheter aortic valve replacement (TAVR). The Certitude Delivery System includes a balloon catheter that expands a compressed transcatheter heart valve, a loader that delivers the valve through the guiding tube, and extension tubing.
It’s been determined that 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 FDA said in a recall notice released January 11.
A total of 1730 devices have been recalled in the United States. They were manufactured between November 22, 2016, and July 10, 2017, and distributed between January 9, 2017, and July 17, 2017.
The model/item numbers are: 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A, 9600SDS20A, 9600SDS23A, 9600SDS26A, and 9600SDS29A. The recalled products have lot numbers between 60677270 and 60990824.
On July 21, 2017, Edwards Lifesciences sent a recall notification letter to affected customers informing them of the defect. The company asks customers to complete the acknowledgment form that accompanied the letter, check all inventory for affected models of the Certitude Delivery System, and return the acknowledgment form and all affected models of the Certitude Delivery System to Edwards Lifesciences.
Customers with questions regarding this recall may contact Edwards Customer Service at 1-800-424-3278, from 6:00 am to 4:30 pm (Pacific Time).
Healthcare professionals are encouraged to report problems related to these devices to MedWatch, the FDA’s safety information and adverse event reporting program.
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