FDA Issues Recall of RotaWire ‘Elite’ Core Wires
Manufacturer, Boston Scientific has issued an urgent recall for various components of the Rotablator Rotational Atherectomy System—a device used to improve the circulation of blood to the heart by opening narrow arteries. Over 700 devices, distributed between July 9 and October 1, 2015, have been effected by the recall, including RotaWire Elite Guidewires and wireClip Torquer Guidewires.
The manufacturer has recalled the devices as a result of receiving three separate reports that the Guidewires may break and separate from the System. The migration of the Guidewires within a patient’s body has the potential to cause major injuries including decreased heart function and heart attack. The defect has resulted in patients undergoing emergency heart surgery; having stents implanted in the affected artery; and even death.
An emergency recall letter was sent on October 9, 2015, instructing distributors to notify customers of the defect and to return any potentially affected devices to the manufacturer. If you are a patient who has undergone an atherectomy procedure, it is important that you contact your physician. If you have experienced an adverse effect after receiving a Rotablator Rotational Atherectomy System, you can report it to the FDA here.