Boston Scientific recalls ICDs, CRT-Ds
This article was originally published in The Silver Sheet
Executive Summary
Boston Scientific is recalling all of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) because it made manufacturing process changes without proper FDA approval. The firm said March 15 that it will stop shipments and retrieve all field inventory of its ICDs and CRT-Ds, including the Cognis, Teligen, Confient, Livian, Prizm, Renewal and Vitality product lines. Boston Scientific said it learned of two unapproved manufacturing process changes during a "planned process review." The changes were validated but not submitted to FDA, the company said. Such changes, if material to the safety or effectiveness of the product, require PMA-supplement approval. The firm is acting "voluntarily and expeditiously" to resolve the issue and has seen "no evidence of any risk to patient safety," CEO Ray Elliott said. The company is not recommending explantation of already implanted devices, and its pacemakers and other products are not affected by the advisory