Product recall lawyers at Pintas & Mullins Law Firm report of a recent recall by St. Jude Medical. The product, a wire used to put devices in place that close heart chamber openings, is called the Amplatzer TorqVue FX Delivery System, and is being removed from inventories throughout the U.S.
The wire was recalled due to its increased potential for fracture when used in patients with certain cardiac anatomies and implant practices. The Amplatzer TroqVue System was used in about 120 procedures since its introduction in 2012. The recalled wires were manufactured between August 24 and September 24 and sold between October 1 and January 9.
St. Jude has been having much trouble with its cardiac problems in recent years, most notably with its Riata Defibrillators, which were recalled in late 2011 in a Class I designation. Class I recalls are reserved for those drugs and products that have the potential to cause serious injury and death in patients. Riata and Riata ST Silicone Endocardial Defibrillator Leads were found to have insulation that could erode inside the body, posing a risk of electric shock and externalized wires.
Despite the widespread, highly publicized recall, nearly 80,000 patients remain implanted with Riata’s still today. This was possible through miscommunications between the FDA, St. Jude, and individual hospitals and physicians. St. Jude claimed it provides detailed information to healthcare providers about recalls, who are then expected to relay that information to affected patients. When NBC Chicago further investigated the issue, several hospitals said that individual circumstances actually dictate how, when, and by whom patients are contacted about recalls.
If a wire erodes or detaches inside the body it can cause perforation and even penetrate though the skin of a patient. Perforation of the heart is an extremely severe circumstance, but is also entirely possible. If defibrillator lead wire malfunction, the risk of cardiac arrest is increased because the device is unable to sense irregular heartbeats and cannot provide the electric shock therapy to keep a patient alive.
St. Jude responded to the Riata debacle by increasing the wire insulation and adding a compound to the silicon around the wires. The small (about the size of a wristwatch) device houses a generator, circuitry, and a battery with small wires attached directly to the heart. The wires are the Achilles Heel, so to speak, of the entire system. If the wires erode, or malfunction in any way, it can fail to tell the defibrillator to send an electrical jolt when the heart goes into an arrest, killing the patient.
Other similar cardiac systems are manufactured by Medtronic and Boston
Scientific. In 2007, Medtronic initiated a recall that affected devices
already implanted in more than 200,000 patients. Two years later, the
company confirmed that about 13 patients had died because of its product’s
defects, which included, of course, wire defects.
Medtronic wound up agreeing to pay nearly $270 million to settle wrongful death lawsuits resulting from the fractured wires. The settlement involved about 8,100 cases – meaning each patients received, on average, about $33,000. Plaintiffs alleged that the wire fractures were caused by poor welding, design, and quality control at manufacturing facilities.
Defective defibrillator lawyers at Pintas & Mullins Law Firm will continue to report on any recalls initiated by St. Jude, Medtronic, and the like. If you or a loved one was seriously injured by a defective medical device, you may be entitled to significant compensation through a lawsuit against the manufacturer. Our attorneys have decades of experience advocating on behalf of patients injured by dangerous devices, and can ensure you will receive the best representation and largest settlement possible.