Boston Scientific has obtained U.S. Food and Drug Administration (FDA) clearance for the two validated manufacturing changes affecting its COGNIS® cardiac resynchronization therapy defibrillators (CRT-Ds) and TELIGEN® implantable cardioverter defibrillators (ICDs) and has resumed U.S. distribution of these devices. Implants of these products may begin immediately.
As you know, on March 15, 2010, Boston Scientific voluntarily stopped United States distribution of all CRT-Ds and ICDs and removed these products from U.S. hospital shelves. We took this action after discovering that we had implemented two validated manufacturing changes in our CRT-D and ICD devices without filing the appropriate documentation with the FDA in advance. No device failures have been associated with these manufacturing changes, nor do we expect any failures in the future related to these changes. As we communicated to physicians in a letter dated March 22, 2010, there is no indication that there are any patient safety risks associated with these changes, and we are not recommending any modifications to normal follow-up procedure for patients previously implanted with Boston Scientific CRT-D or ICD devices.
Geographies outside the United States were never affected - and remain unaffected - by the product removal actions.
For additional information, select the following links to the U.S. physician letter and U.S. patient letter.
Published April 21, 2010
