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What you need to know about defective medical devices

A defective medical device could lead to serious health issues. Complications caused by a defective device could lead to costly medical bills, lost wages, emotional distress, and decreased quality of life. Read on to learn more about medical device recalls, how the Food and Drug Administration handles defective device claims, and what you should do if you’ve been hurt.

Medical device recalls

The FDA lists all recalled medical devices on their website. Here is a list of 2019 recalled medical devices. They include devices as common as catheters and as sophisticated as 3D brain imaging software intended to assist surgeons to guide their instruments.

In the case of the brain imaging software, it was on the market from 2011 to 2018 but was only recalled in January of 2019. It was a Class 1 recall, the most dangerous type, meaning it could lead to death or serious injury. Because the brain software was in use for at least eight years before it was recalled, there could be numerous patients who were harmed or even killed as a result of the faulty device, which inaccurately depicted the exact location of a surgeon’s tool, which may lead to accidental damage to brain tissue.

The FDA’s 510(k) process

You might be wondering how medical devices are so often defective or don’t achieve their intended purpose. This is partly because of the FDA’s 510(k) process. According to the FDA, “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA (Premarket Approval).” Basically, this means that new medical devices can be approved in an expedited manner if the manufacturer can prove that it is similar enough to a previous one that was already approved.

According to CNBC, the FDA approved 3,173 devices through this system, or 82% of the total devices cleared. The FDA claims they have plans to overhaul the system so that devices older than 10 years cannot be used as predicates, which are the legal devices used to demonstrate that the new one is substantially equivalent to it.

What to do if a medical device injures you

If you have been injured because of a defective medical device, please consider reaching out to the experienced product defects attorneys at Hach & Rose, LLP. Call us at (212) 779-0057 to schedule a free, no-obligation consultation to discuss how we can help you.


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