FDA: Boston Scientific recalls RotaWire Elite and wireClip Torquer Guidewires

Editor's Note

Boston Scientific Corporation is recalling RotaWire Elite core wires because they may crack and separate from the rest of the Rotablator Rotational Atherectomy System and cause serious injury such as tamponade, myocardial infarction, and migration of wire fragments, the Food and Drug Administration reported November 27.

Boston Scientific has received three reports of this issue occurring, including one death. The system is used to open coronary arteries.

Posted 11/27/2015] AUDIENCE: Risk Manager, Biomedical Engineering, Cardiology ISSUE: Boston Scientific Corp is recalling RotaWire 'Elite' core wires because they may crack and separate from the rest of the Rotablator Rotational Atherectomy System and cause serious injury such as tamponade (blood in the sac around the heart causing decreased heart function), myocardial infarction (heart attack), and migration of wire fragments elsewhere in the body.