Heart devices and the companies that manufacture them have had a rocky road the past few years (excluding Medtronic’s failed Sprint Fidelis leads: despite needlessly shocking patients, claims for injuries have been found by a federal trial court to be preempted). These include Guidant, which was subjected to recalls and numerous lawsuits over its defibrillators because of a short-circuiting problem.
Now, Boston Scientific (which acquired Guidant in 2006) has voluntarily recalled all (non-implanted) implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). An ICD is a device that monitors heart rhythms and delivers life-saving shocks if dangerous rhythms are detected. A CRT-D treats certain types of heart failure by coordinating the pumping of the heart’s ventricles. The units recalled fall under the COGNIS, CONFIENT, LIVIAN, PRZM, RENEWAL, TELIGEN and VITALITY lines.
The reason for the defibrillator recall is that Boston Scientific realized that two manufacturing process changes were made and not pre-approved by the FDA. Boston Scientific is telling doctors not to implant any more of their ICDs and CRT-Ds, and to return all inventory stored by doctors and hospitals. They are not recommending removal of the devices that have been inserted, commenting that there is no evidence of risks to patient safety. In fact, some commentators have been rather glib on this point—one doctor interviewed stated “My goodness, to suddenly stop selling all these devices based on not dotting the ‘i’ or crossing the ‘t,’ I think is an overreaction, if indeed that is the reason.” The reason that seems glib is that there is no indication of exactly what the manufacturing process changes were, and whether they are likely to be approved. They probably will be, but there is no information on the details.
Regardless, the important thing to note is that Boston Scientific, which has been hard at work to breathe life into the ailing Guidant unit since purchase, was faced with the facts that their protocols missed the need for an FDA submission. Rather than hiding it, they immediately stood up and responsibly recalled the defibrillators. This will certainly cost them a lot of money (these devices were 15% of Boston Scientific’s revenue last year, totaling $1.79 billion. One report stated that the recall could cost them $5 million per day), and the decision likely wasn’t easy, but they did the right thing. Once they straighten this out, if I ever needed a heart device, I’d be more likely to use Boston Scientific than Medtronic.