Medical Device Recall: What to do

Medical device recalls happen quite often. As a matter of fact, there is a running list of medical device recalls on the FDA website. So, what do you do if you hear about or receive notice, of a medical device recall that you are using; especially if that device is in the form of an implant?

First, it’s important to understand the Food and Drug Administration (FDA) recall process. A recall is defined as, “an effective method to remove or correct FDA-regulated products from the marketplace.” Recalls are often necessary because, unfortunately, many medical devices go to market without adequate testing. The FDA determines whether a medical device is safe, but sometimes device safety is only determined after the device has been utilized in real life.

Doctors and consumers report on their experiences, and healthy issues are then reported to the product manufacturer. Once a pattern is established, if the manufacturer does not voluntarily issue one, the FDA may recommend, or require, a product recall. Depending on the seriousness – a Class III, II or I recall – a recall may require the manufacturer to alter or replace faulty devices. A Class III recall is for products that may not cause serious health issues. A Class II is for recalls that may pose a temporary problem, but not a serious medical issue. A Class I, which requires immediate action, is issued for products that will cause serious issues or, even, death.

A medical device recall doesn’t always mean the device has to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.

If a medical device you are using is recalled, there are some practical steps you can take. Depending on the seriousness of the recall, and your doctor’s advice, you can choose the next steps. If there is a serious recall, you will, most likely, receive notice from the medical device manufacturer. If you do receive a recall notice, you should contact your doctor immediately to discuss options for switching out or altering the device. If you have experienced dangerous side effects as a result of using the medical device, make sure to report these side effects to your doctor, the manufacturer and the FDA.

While the medical repercussions may be reversed, sometimes they are not. Medical device companies are required to rigorously test devices before they are made available to the public. Unfortunately, this is often not the case, and innocent people suffer as a result. As a result, individuals hurt from a medical device malfunction may be entitled to compensation. If you, or someone you care about, have been negatively affected by the use of a faulty medical device, you may be eligible for compensation. Contact the law offices of Martin Harding & Mazzotti, LLP® at 1.800.LAW.1010 for more information. We are here to help.