A Medical Device Daily
Boston Scientific (Natick, Massachusetts) reported that it is voluntarily recalling certain lots of the Mach 1 guide catheter in the U.S. It said the total number of devices involved in the recall is estimated at 51.
The guide catheter is a tube that is threaded through the body and allows delivery of medical devices to the heart to treat coronary artery disease.
The company said it is initiated the recall because it 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 small blood vessel by an embolism may not cause tissue damage, it said. But it added: “however, 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.“
The company said there have been no product complaints reported to it related to this issue, and no reported injuries.
The products affected by this recall were distributed only to hospitals in the U.S. The company said it is notifying affected hospitals via recall notification letters requesting that use of the product affected by this recall should cease immediately. Replacement product will be available for all affected product.
The affected lots of Guide Catheters are 687532, 687586, 687593, 687596, 687654, 687753, 687754, 688035, 687877, 687878, 687879 and 688002. The company said it has notified the FDA concerning the recall action.