The Company has determined that some manufacturing process changes were not submitted for approval to the U.S. Food and Drug Administration (FDA). At this time, the company has identified two instances of changes that, while successfully validated, were not submitted to the FDA. Boston Scientific has informed the FDA and plans to work closely with the agency to resolve this situation as soon as possible.But the interesting part of this news is who knew first. According to theheart.org:
The Company has no indication that the manufacturing process changes pose any risk to patient safety, and it is not recommending explantation of the devices.
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.
Analyst reports were among the first to trumpet the news, even before Boston Scientific issued its alert. Larry Biegelsen of Wells Fargo Securities predicted early this morning that the news will mean "reputational damage" for the company, despite the fact that the problem appears to be "administrative."And here I thought the big news of the day was going to be at the meeting.