FDA Issues Alert on Guidewire Recall
The U.S. Food and Drug Administration (FDA) has issued an alert that Boston Scientific Corp. is recalling RotaWire ‘Elite’ core wires. The RotaWire Elite Guidewire and wireClip Torquer Guidewire are part of the Rotablator Rotational Atheroctomy System, a device used to open narrow arteries and improve blood flow to the heart.
According to the company, the wires may break off from the system, leading to serious injury such as tamponade, myocardial infarction and migration of wire fragments to other parts of the body. Boston Scientific’s recall instructs health care professionals to stop distributing and using the wires immediately.
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