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What should I know about medical device recalls?

When a medical device doesn't work as intended or ends up causing negative side effects, the device might be recalled. In some cases, the device that is recalled might not comply with the FDA's laws governing the device. There are some very important points that anyone with a medical device should know about recalls.

Are there different types of recalls?

There are two types of recalls: removals and corrections. Removals are recalls that pull the devices from where they are sold or used. Corrections are recalls that impose a change that takes place where the devices are sold or used.

Should all recalled medical devices be removed?

Just because a device is recalled doesn't mean that it has to be removed or that a patient has to stop using it. Some recalls are issued to warn medical professionals that the medical device should be checked for certain problems. Some are issued to warn that the device may fail prematurely.

What are some actions initiated by a recall?

There are several different actions a recall can initiate. Patients might be notified of potential problems, devices might have to be repaired, settings might need to be adjusted, devices may need to be destroyed, or patients with the device might need to be closely monitored.

When a medical device manufacturer issues a recall for a medical device, the FDA is notified. While some recalls don't affect patients much, anyone who is affected by a medical device recall should determine if they are interested in seeking compensation to help cover the costs of the damages caused by the defective medical device.

Source: United States Food and Drug Administration, "What is a Medical Device Recall?," accessed April. 13, 2015

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