The FDA has recalled 12 lots of Boston Scientific’s Mach 1 Guide Catheters. These devices are tubes that are thread through the body and used to help treat coronary artery disease. Excess strands of resin may be inside of some of the catheters. In the event that excess resin is present and detaches while the catheter is being used in treatment, embolization may occur. Embolization in a blood vessel can lead to serious complications such as stroke and heart attack.
Comments are closed.