On March 15, 2010, Boston Scientific announced that it had voluntarily stopped United States distribution of all implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) and is removing unimplanted products from U.S. hospital shelves. We initiated this removal after an internal documentation review revealed that two manufacturing changes were successfully validated and implemented, but were not submitted for approval to the U.S. Food and Drug Administration (FDA). Boston Scientific has informed the FDA of this removal action and has submitted required documentation to secure approval of the manufacturing changes.
It is important to understand that this action is in response to a regulatory filing omission rather than a product quality or patient safety issue. There are no indications that these manufacturing changes pose any risk to patient safety. There have been no device failures associated with these manufacturing changes nor are any failures expected in the future. Boston Scientific is not recommending device explantation or any changes to normal follow-up procedure for patients implanted with our ICD or CRT-D devices.
NOTE: ICDs and CRT-Ds sold in other geographies are unaffected by this action. In addition, Boston Scientific pacemakers, brady and tachy leads, lead delivery systems and accessories are unaffected by this action.
For additional information, select this link to the U.S. physician letter.
A Closer Look articles provide educational/training information on a variety of topics to better understand the function of Boston Scientific CRM products. Articles are now available at bostonscientific.com and bostonscientific-international.com (A4 format and translations, where available).
Published March 30, 2010
