Boston Scientific (NYSE:BSX) recalled nearly 1,000 components used with its Rotablator atherectomy device after receiving 3 reports that the catheter’s guidewire fractured during procedures to remove plaque from the coronary arteries.
In 1 case, the patient died 4 days after the wire fractured and the device’s rotating burr, moving at 195,000 to 200,000 rpm, pierced the artery wall, according to the FDA’s adverse events database.
In an Oct. 8 letter to customers, Marlborough, Mass.-based Boston Scientific recalled 955 of the RotaWire Elite and WireClip torquer components.
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