US medical devices maker Boston Scientific Corporation on Monday announced that it halted sales of its implantable defibrillators after failing to inform federal regulators to changes made in manufacturing of its best-selling devices.
Boston Scientific said in a statement that it has stopped shipment and is recalling unused units of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).
Boston Scientific played down the problem, which took the industry by surprise, by saying that it failed to submit some manufacturing process changes for Food and Drug Administration (FDA) approval.
Although the Natick, Massachusetts-based company said that it has identified two instances of changes that, while successfully validated, were not submitted to the FDA, it refused to describe the process changes that made it halt sales of its best-selling devices on the ground that they are proprietary.
The halt in sales involve seven brands of defibrillators, implantable devices that regulate heart beats and also send electrical pulses to the hearts of patients when it senses cardiac arrest.
These devices generated approximately 15 per cent of Boston Scientific's 2009 sales of $8.2 billion.