On February 15, FDA announced that Abbott Vascular has received nine reports of its MitraClip delivery system failing to detach from the Clip, which resulted in the death of one patient and open-heart surgery to extract the device. The problem can also cause its mandrel component to fracture. “Tension is present if the Arm Positioner is on the ‘Closed’ side of Neutral, as opposed to being in the Neutral position during Clip deployment,” reads the company’s field safety notice.
Abbott’s response to the problem was to recall the delivery system and provide updated instructions and training for clinicians using the device.
