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What are different kinds of medical device recalls?

On Behalf of | Apr 22, 2022 | Product Liability

Sometimes a medical company discovers that one of their medical devices has a defect that could cause harm to a patient and issues a recall. Medical device recalls are important to pay attention to because you may need to stop using a device as soon as possible to safeguard your health. However, not all recalls require you to take the same actions.

It is common to think of a recall as returning a product to its manufacturer. However, the U.S. Food and Drug Administration explains that medical recalls may take different forms. Understanding what a recall requires of you may help you prevent danger to your wellbeing.

Adjusting or repairing a device

The recall information may require you to go to a doctor or another specialist to have your device examined. Sometimes a device will not present a threat if a medical professional adjusts the settings in the device or repairs a defect. A doctor might also want to monitor you for health problems even if a device does not possess any apparent problems.

Explanting a device

In some situations a device poses enough of a threat that leaving it in your body may be dangerous. The FDA determines device dangers through a scale of three different classes, with Class III the least likely to harm you and Class I the most likely to endanger your health or life. A manufacturer that grades a device with the highest danger level may recommend removal of the device and that you return the device to the manufacturer or destroy it.

However, removing and destroying a device is not always recommended. The recall may point out that removing a device also poses a risk. The manufacturer will probably ask that your doctor talk with you about whether you might be at greater risk of removing the device as opposed to leaving it in place.

Be aware of potential liabilities

Getting the right information in time might save you from disability or death. Sometimes a medical company fails to recognize that one of its products is dangerous, and patients suffer because of the omission. Still, whether a recall exists or not, you might have a case for liability if you suffer injury from a defective device.

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