Boston Scientific halts defibrillator shipments, retrieves devices

Boston Scientific Corporation announced today that it has stopped shipment and is retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

The company said it failed to notify the U.S. Food and Drug Administration of some manufacturing changes to its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. Boston Scientific has informed the FDA and “plans to work closely with the agency to resolve this situation as soon as possible.”

Boston Scientific said there is no evidence the devices are faulty and isn't recommending patients have them removed because the changes pose no risk to patient safety. Product families included in this advisory include Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality. The company's pacemakers and other products are not affected by this advisory.

“We are acting voluntarily and expeditiously to resolve this situation, and we have seen no evidence of any risk to patient safety,” said Ray Elliott, president and Chief Executive Officer of Boston Scientific. “We apologize for the inconvenience these actions will cause patients and physicians.”