March 31, 2010 — Boston Scientific Corp. recently announced that it has stopped shipment and is retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), after a planned process review revealed that two manufacturing process changes were not submitted for FDA approval.
Boston Scientific has informed the FDA and plans to work closely with the agency to resolve this situation as soon as possible.
Product families in this advisory include: Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality. 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.”
The company is not recommending explantation of the devices.
Given the financial uncertainty involved, these actions may have a material impact on previously issued guidance, including revenue, operating profit and cash flows for the first quarter and full year of 2010, stated Boston Scientific. The company plans to fully evaluate the impact of these actions on its financial results and provide an update when the evaluation is completed.
For more information: www.bostonscientific.com