In the wake of three deaths, Boston Scientific Corp. recently issued a worldwide recall of its Lotus transcatheter aortic heart valve replacement system. The recall is voluntary and not mandated by any government entity. The recall affects approximately 250 Lotus valve systems that were manufactured earlier this year, roughly fifteen (15) of which are in the United States. The Lotus valve is available for purchase in Europe, but only through clinical trial in the U.S.
The defect involves a component that may break as the device is implanted in the patient. Presently, there are at least three instances in which the malfunction resulted in what the recall deemed “catastrophic vessel trauma associated with patient death.” The component – known as the “release mandrel” – is not left in the patient, and therefore the recall should not affect the safety of those individuals who have already had the device implanted.
The technology is relatively new. The Lotus valve system can be implanted without major surgery because they’re designed to fit into narrow tubes called catheters. The catheters are inserted into a blood vessel and advanced to the heart using the patient’s vascular system. This innovation has eliminated the need for open-heart surgery, and the market for this new technology is expected to exceed $1.8 billion over the next five years.
Tragically, in a rush to introduce a new product on the market, manufacturers do not always prioritize consumer and patient safety. For decades, the experienced attorneys at Swartz & Lynch have provided legal representation to victims of defective products. If you have been injured because of the negligence of another or because of an unreasonably safe product, you may be entitled to compensation for your injuries.