Boston Scientific Announces Nationwide Recall of 51 Mach 1 Guide Catheters
Boston Scientific Corporation today announced that it is voluntarily recalling certain lots of the Mach 1 guide catheters in the United States. The affected lots of Guide Catheters are 687532, 687586, 687593, 687596, 687654, 687753, 687754, 688035, 687877, 687878, 687879 and 688002. The total number of devices involved in this recall is estimated at 51.
The tube is thread through the body to allow delivery of medical devices to the heart to treat coronary artery disease. Boston is initiating this recall because it 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. 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. According to the company, no product complaints have been reported so far related to this issue, and there have been no reported injuries.
December 15, 2006 Related topics: Product Recalls, Cardiology