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Class I recall of valve delivery system initiated by Edwards Lifesciences

A recall was initiated by Edwards Lifesciences involving 1,730 units of its Certitude Delivery System, which is intended to deliver the Edwards SAPIEN 3 transcatheter heart valve. The Class I recall was initiated because the overflow material in the button valve inside the system's loader may detach during system placement, potentially leading to an embolism that could cause blood flow obstruction.

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