Boston Scientific Defibrillators’ Sales Suspended

Boston Scientific has suspended sales and recalled two of its most popular cardiac defibrillators because changes to manufacturing processes weren’t approved by the FDA. The suspension and recall affects seven Boston Scientific implantable defibrillators. Products affected by the move were the Cognis, Confient, Livian, Prizm, Renewal, Teligen, and Vitality brands. The action did not affect Boston Scientific’s pacemakers and other medical devices.
While they wouldn’t comment publicly on the issue, Boston Scientific officials will work with the FDA to resolve the problem in an expeditious manner. There is no evidence at this point that the Boston Scientific defibrillators pose any health risk to patients unlike the Sprint Fidelis defibrillator leads manufactured by Medtronic. These leads were recalled in late 2007 after they were found to break causing inconsistent electrical impulses to the heart muscle.