Sunday, 16 of December of 2018

FDA Issues Class I Recall Over Medical Device Used In Heart Surgery

By Kevin Duffan, VA/NC Medical Malpractice Attorney

What Happened:

The FDA recently announced a recall by St. Jude Medical. The recall, released at the end of last month, concerns a device used in heart surgery and has been given the most serious level warning by the regulatory agency.

According to the FDA, in some cases a wire in the Amplatzer TorqVue FX Delivery System can fracture while it is being implanted in the two upper chambers of a patient’s heart. This carries a risk of not only serious injury but also death.

For the devices not yet implanted in patients, St. Jude Medical sent a warning to doctors labeled “Urgent Medical Device Recall Notice” asking that they immediately stop using the device and return any unused inventory they may have.

The recent recall was labeled a Class I, meaning that it is the most serious type of recall given that there is a reasonable probability that using the product will result in adverse health consequences or death.

The Virginia Injury Lawyer’s Perspective:

Any story about dangers related to a person’s heart is shocking. We all hope that companies responsible for making such critically important devices do a good job. While most do, some companies refuse to invest the time or money needed to ensure that the products they manufacture are completely safe.

If you or a loved has been injured by a medical device and have questions, come talk to one of our Virginia personal injury attorneys about what possible legal options you have to receive compensation. Attorneys with our Virginia personal injury law firm have helped many victims of dangerous and defective products recover damages from companies whose negligence or disregard for consumer safety led to injuries.

Helpful Info:

If you’ve been injured by a defective product it’s essential that you consult with a Virginia personal injury attorney who has experience handling similar cases. Our firm has successfully represented a variety of clients who have been injured by defective or dangerous products.

To begin to learn about your rights and possible options for filing a civil claim for compensation, read through the following article about defective products written by our firm’s personal injury attorneys.

Got Questions? 

Those who have been injured by a medical device or fear they may be impacted by a medical device recall surely have lots of questions. You might be wondering about what you should do if you’ve been injured by a medical device, what the legal definition of a “defective product” is, or what the requirements of a successful product liability are. For answers to these and other frequently asked questions regarding recalled products check out the following guide.


About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis, Appleton & Favaloro include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Attorneys with our firm have been listed among the Best Lawyers in America since 2008. Attorneys with our personal injury law firm have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of practicing attorneys receive.