The AP is reporting that Boston Scientific has suspended the sale of its defibrillators after it found a documentation error related to the manufacturing of the devices. The company is also taking all inventory of the devices that weren't made in compliance with FDA regulations. According to the Boston Business Journal, the recall could have a "material impact" on its 2010 financial guidance. "A planned process review revealed that two manufacturing process changes were not submitted for FDA approval," said Boston Scientific President and CEO Ray Elliott in a statement. “We are acting voluntarily and expeditiously to resolve this situation, and we have seen no evidence of any risk to patient safety. We apologize for the inconvenience these actions will cause patients and physicians.”

Despite the recall, the company isn't recommending that doctors remove the devices from patients. Recalled devices include the Cognis, Confient, Livian, Prizm, Renewal, Teligen, and Vitality lines, according to the Boston Business Journal.