Abbott Laboratories just issued a recall of its MitraClip system. The device is used to pin together leaky heart valves, but part of this delivery catheter can dislodge and fall off when the catheter is withdrawn, The Heart reported, citing confirmation from Abbott Laboratories.
Abbott said that there have been three cases in which a ring designed to make the catheter visible to imaging equipment fell off. One case also involved a situation in which a patient died days following surgery to remove the ring, according to Medscape.
The global recall affects all markets including the United States. The MitraClip is not sold in the U.S., but is being studied. Abbott has high hopes for substantial sales in the U.S.
The recall does not affect the clip itself and patients implanted with the clip are not impacted by this recall.
“We’re working on a minor modification to the delivery catheter and expect to resume shipments as soon as possible,” Abbott spokesman Jonathon Hamilton said, quoted The Heart.
The device is described as “clothespin-like” device that is introduced via blood vessels by catheter to the heart. There, it is sent to “pin together” leaky mitral valves, said The Heart, which explained that patients with valve issues usually undergo repair and replacement in the more complex open-heart surgery.
MitraClip sales amount to some $10 to $20 million quarterly, noted The Heart.