A guidewire assembly used to improve blood flow to the heart was recalled due to a potential for lethal injury. One death has been reported as a result of a broken wire.
The affected devices are the RotaWire Elite Guidewire and wireClip Torquer Guidewire, components of the Rotablator Rotational Atherectomy System, manufactured between June 26 and Sept. 10, 2015 and distributed between July 9 and Oct. 1, 2015. It is used in atherectomy, a process in which narrowed arteries are opened and blood flow to the heart is improved by the removal of plaque from the artery wall. The core wires are known to separate from the rest of the device and cause serious injury, including tamponade (blood in the sac around the heart, which causes decreased heart function), heart attack, and migration of the wire fragments to other parts of the body.
One patient died after a medical intervention was put into effect in order to remove a broken wire from the body. In other cases, interventions such as blocking off affected arteries, placing stents in the affected arteries, and emergency heart surgery have been necessary.
In the United States, 600 units have been recalled.
Distributor Boston Scientific recommended that medical practitioners stop using these devices immediately, and return them to Boston Scientific using the recall form.
