Abbott Recalls MitraClip System

Abbott Laboratories has issued a worldwide recall of its MitraClip system after discovering that part of a delivery catheter can fall off when the catheter is withdrawn. The MitraClip system is used to pin leaky heart valves together.

The recall affects all markets. Abbott cited three cases where a ring designed to make the catheter visible to imaging equipment fell off; in one case, a patient died in the days following ring removal surgery. The recall does not affect the clip itself and there is no risk of infection to those who already have had one implanted.

“We’re working on a minor modification to the delivery catheter and expect to resume shipments as soon as possible,” said company spokesman Jonathan Hamilton. Abbott is expecting a mid-2011 U.S. Food and Drug Administration review by a panel of outside experts and potential U.S. approval by the end of this year.

The recall is not expected to have a major financial impact. Abbott has reported that sales range between $10 and $20 million per quarter.