Many Houston area residents have a heart condition or have a family member with a heart condition. Heart disease is the number one cause of death for Americans and most people are aware of the problems that can arise if they don't take care of their heart. Medtronic, as a leading medical device maker, has many products designed to help heart disease. One of these has been recalled because it is a defective medical device.
Medtronic has announced that it is recalling a loading system for a heart device. The product is called Enveo R Loading System and is part of the company's CoreValve Evolut R system. This product was recently cleared for sales in the U.S. in June. The product is used on patients who suffer from severe aortic stenosis where an aortic valve narrows. The product is for a transaortic valve replacement.
The FDA has classified the recall as a "Class 1," which means the product can cause serious injury or even death in patients who have this device. Medtronic said it has received eight reports of problems with the device. The company issued a letter explaining that the device can cause a presence of particulates that can lead to blockage in the blood stream. Medtronic has removed the product from the market.
A medical device failure can lead to unexpected serious injuries for patients. Many times, medical device manufacturers are too quick to put their product on the market and do not do the testing necessary to make sure their product is safe. An attorney who is experienced with such cases can help a family who believes they have been affected by a defective medical device. An attorney can review medical records, investigate the medical device and hold the medical device manufacturer responsible for the injuries they cause. Compensation may be available for medical expenses, pain and suffering and other damages.