A recall of over 7,000 heart device loading systems may affect New Jersey patients. Medtronic Plc manufactured the device, which was approved for sale in the United States in June. The product is relied on by individuals who have a serious heart condition called aortic stenosis, or narrowing of the arotic valve.
According to the report, a representative for Medtronic Plc stated that as of July 6, there were eight reported instances associated with 7,347 EnVeo R Loading Systems, although none of the complaints resulted in anyone being adversely affected. The representative also noted that none of those units were sold for commercial use within the U.S. and that Medtronic has resolved the issue by improving its manufacturing procedures of the product. The complaints involved particulates that were said to be found in the Evolut device, which could cause blockage in a patient's bloodstream. All the affected products were taken off the market, according to the report.
The device is part of the company's CoreValve Evolut R system and is primarily used for transaortic valve replacement (TAVR). The product is a safe alternative to surgery. The unit recall has been classified as Class 1 by the U.S. Food and Drug Administration. This classification implies that if a consumer uses the device or is exposed to it, it can potentially lead to severe repercussions or death.
Consumers who rely on a manufactured product for their medical needs and are seriously injured as a result of the product may be eligible to file a products liability claim. A personal injury attorney who handles product liability cases may be able to assist a victim with pursuing damages if it can be proven that the victim's injuries were caused by a defective product. If the claim is successful, the plaintiff may be awarded compensation stemming from use of the defective product, such as medical expenses and income losses.
Source: Reuters, "Medtronic recalls loading system for heart device," August 6, 2015