St. Jude Medical recalled its Riata and Riata ST implantable cardioconverter defibrillators, not its pacemakers, because the erosion of insulating material resulted in the unsafe protrusion of electrical wires, according to the FDA. Some defibrillators contain pacemakers, but defibrillators differ from pacemakers in how they function and support cardiovascular health.
Pacemakers help the heart beat at the proper rate. Defibrillators monitor heartbeat and deliver an electric shock to the heart when the heartbeat is chaotic or too fast, explains the University of Iowa Hospitals and Clinics.
St. Jude Medical has not sold the affected ICDs since 2010 but distributed roughly 227,000 prior to this, states the FDA. St. Jude Medical issued the product recall subsequent to allegations of device breakdowns, dangerous shocks and substandard design, according to FierceMedicalDevices.
ICDs have a general lifespan of 10 years, explains the FDA. As of 2015, there are documented cases of St Jude Medical's ICDs malfunctioning or failing to work well in advance of their 10-year lifespan and of patients dying when doctors attempted to extract Riata ICDs. When St. Jude Medical pulled its ICDs from the market in 2010, it cited problems with externalized conductors as a result of inside-out abrasion, reports MassDevice.com
The original Riata recall received a class 1 recall status from the FDA, which indicates that the exposure to a particular product may result in serious injury or death, reports MassDevice.com.