Thousands of faulty heart devices recalled
The U.S. Food and Drug Administration has designated the product recall by a medical device manufacturer as Class 1. The faulty medical units are the loading systems for a medical device used in the treatment of severe aortic stenosis, the narrowing of the aortic valve. Heart patients in Essex may have heard of transaortic valve replacement. It is the procedure that involves the faulty system in cases where surgery is considered too risky. The Class 1 recall designation reflects the reasonable likelihood of injury or death to the consumer using the product.
The recall was announced after the manufacturer discovered that their loading system was contaminated with particulates. In a letter sent to its customers, it said that the product could be hazardous if the particulates entered the bloodstream and caused a blockage. A spokesperson confirmed that they had improved their processes in the manufacture of the device and that the production problem had been resolved.
The loading system had only been approved in June, but by July 6, the company had received 8 reports of contaminants in their product. None of the affected medical devices had been sold to customers in the U.S., and the manufacturer had no reports of patients suffering adverse effects from using the product. Although 6,912 units have been recalled, 7,347 potentially faulty systems were released.
A successful claim against a manufacturer of a faulty product involves showing that the device was defective. When a company announces a recall and admits that their product was faulty, a solicitor knowledgeable in product liability cases may be able to advise a client of the legal procedures necessary to raise a claim. Any compensation that is awarded is likely to take into consideration the extent of the injuries suffered by the victim and the subsequent financial losses that have been incurred.