St. Jude Medical Inc, one of the giants of the medical device industry, has announced that it is recalling some of its internal pacemakers after a defect in the devices' batteries came to light. Though St. Jude claims the risk of serious harm to patients is low, at least two users of the devices have died so far.
The devices affected by the recall are called ICDs and CRT-Ds. Both are implanted in the chests of people dealing with heart failure or arrhythmias, and are designed to shock the heart when it is racing dangerously high in order to return it to a normal rhythm. Approximately 400,000 of the recalled devices are currently in use, according to Reuters.
The problem with the devices is that as designed and advertised they were supposed to last at least seven years. However, it turns out that the batteries in the devices carry a risk of premature depletion of power due to a buildup of lithium clusters. Two deaths have been linked to premature failure so far.
The recall is a warning to users, who are being encouraged to visit their doctors. St. Jude is discouraging patients from having their pacemaker replaced, saying the risk of surgery is higher than living with the potentially lethal defect.
That decision on what to do about the defective pacemakers is one best left to patients and their doctors. Patients with a St. Jude pacemaker were counting on the device to treat their illness and extend their lives, not to put them at serious risk.
When someone has been harmed by a defective medical device, as soon as they are able they should contact a products liability attorney to discuss their options.