BOSTON SCIENTIFIC RECALLS GUIDE CATHETERS

Boston Scientific announced last week it is recalling some lots of the Mach 1 guide catheter in the U.S. The firm estimated a total of 51 devices are involved in the recall and said it has notified the FDA of the action.

The guide catheter is a tube that is threaded through the body to allow delivery to the heart of devices to treat coronary artery disease, the firm said. The recall is being initiated because the company "has determined, through internal inspections, that in some product units, excess strands of resin may exist in the inner lumen near the hub of the guide catheter." If the excess resin is present in the catheter and detaches during a procedure, "there is the potential for embolization, in which strands of resin could obstruct a blood vessel."

While this may not cause tissue damage, an obstruction of a major blood vessel or multiple small blood vessels "could result in serious complications such as stroke, heart attack or kidney problems," Boston Scientific said. The firm said it has received no product complaints to date, and "there have been no reported injuries."